Alvotech er fjölþjóðlegt hátæknifyrirtæki í fremstu röð, þar sem yfir 1000 starfsmenn af um 64 þjóðernum vinna að því að móta framtíðina á sviði líftæknilyfja og auka aðgengi sjúklinga um allan heim að hágæða lyfjum. Margir af færustu vísindamönnum landsins starfa hjá fyrirtækinu. 

Við leyfum fjölbreytileika, forvitni og frumkvæði starfsfólks að njóta sín. Við bjóðum aðlaðandi starfsumhverfi í stöðugri mótun og ögrandi verkefni. Alvotech tryggir að jafnrétti kynjanna til launa og frama nái til allra starfsmanna, hérlendis jafnt sem erlendis. Við viljum laða að okkur færasta fólkið á hverju sviði, án tillits til uppruna eða kyns. Með þessum hætti getum við best þjónað hagsmunum sjúklinga og samstarfsaðilum okkar. 

Vertu með okkur í að bæta lífsgæði fólks og auka aðgengi að hagkvæmum líftæknilyfjum. 


1001-5000

Meginmarkmið jafnlaunavottunar er að vinna gegn kynbundnum launamun og stuðla að jafnrétti kynjanna á vinnumarkaði.

Jafnlaunavottun

Vefsíða

Facebook

Instagram

Twitter

LinkedIn

Hreyfing

Samgöngur

Matur

Fjarvinna

Starfsumhverfi

Alvotech is looking to hire a&nbsp;Senior Principal Scientist&nbsp;to lead and innovate within our&nbsp;clinical pharmacology team. This role offers the opportunity to make a significant impact on our clinical programs and contribute to the development of groundbreaking therapies.
We seek a highly experienced scientist with a deep understanding of clinical pharmacology, PKPD analysis, and population modelling. Your expertise will be crucial in designing and planning clinical trials, developing regulatory documents, and ensuring compliance with global standards.
At Alvotech, you will play a key role in our mission to improve global access to affordable medicines. You will be part of a dynamic team dedicated to scientific excellence and innovation, enjoying a collaborative work environment, opportunities for professional growth, and the chance to contribute to transformative therapies.
Please note that international travel may be required to support departmental activities.

Scope &amp; Responsibilities:
<ul>
<li>Lead clinical pharmacology activities for assigned clinical programs/trials.</li>
<li>Develop and revise relevant sections of regulatory documents and deliverables.</li>
<li>Develop the clinical pharmacology strategy, briefing book, study design, and protocol development. Collaborate with biostatisticians on Statistical Analysis Plans (SAPs) and review mock-up displays for tables, listings, and figures.</li>
<li>Provide statistical consultation to clinical teams and support decision-making processes.</li>
<li>Ensure GCP compliance and high-quality standards for Alvotech's sponsored clinical trials.</li>
<li>Support internal and external resources in assay development and validation.</li>
<li>Work independently and as part of a multifunctional team to achieve project deliverables.</li>
</ul>

Job Requirements:
<ul>
<li>Master's Degree in a related discipline (PhD in Clinical Pharmacology or related discipline with relevant experience is desirable).</li>
<li>Minimum 10 years of experience in clinical trials or clinical pharmacology.</li>
<li>Expertise in PKPD analysis, population modelling, and simulation.</li>
<li>Experience with large molecules and biosimilars is desired.</li>
<li>Excellent written and verbal communication skills.</li>
<li>Proficiency in technical software such as Phoenix, WinNonlin, SAS, R, Monolix, and NONMEM.</li>
<li>Strong organizational and management skills.</li>
<li>Deep knowledge of ICH-GCP and regulatory guidelines.</li>
<li>Proven ability to collaborate effectively within cross-functional teams.</li>
<li>Strong interpersonal skills, including the ability to build team spirit and communicate openly.</li>
</ul>

What we offer:
<ul>
<li>An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.</li>
<li>The chance to be part of a global and fast-growing company.</li>
<li>An international work culture that encourages diversity, collaboration, and inclusion.</li>
<li>Positive, flexible, and innovative work environment.</li>
<li>A clear and developed organizational structure.</li>
<li>Training and global opportunities to advance.</li>
<li>A good work-life balance.</li>
<li>Home internet and home office equipment.</li>
</ul>

Why Alvotech
At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We&rsquo;re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.
True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let&rsquo;s create a healthier world together, through affordable biologic medicines.

Alvotech hf


Alvotech is looking to hire a
Senior Principal Scientist
to lead and innovate within our
clinical pharmacology team. This role offers the opportunity to make a significant impact on our clinical programs and contribute to the development of groundbreaking therapies.

We seek a highly experienced scientist with a deep understanding of clinical pharmacology, PKPD analysis, and population modelling. Your expertise will be crucial in designing and planning clinical trials, developing regulatory documents, and ensuring compliance with global standards.

At Alvotech, you will play a key role in our mission to improve global access to affordable medicines. You will be part of a dynamic team dedicated to scientific excellence and innovation, enjoying a collaborative work environment, opportunities for professional growth, and the chance to contribute to transformative therapies.

Please note that international travel may be required to support departmental activities.



Scope &amp; Responsibilities:


 - Lead clinical pharmacology activities for assigned clinical programs/trials.

 - Develop and revise relevant sections of regulatory documents and deliverables.

 - Develop the clinical pharmacology strategy, briefing book, study design, and protocol development. Collaborate with biostatisticians on Statistical Analysis Plans (SAPs) and review mock-up displays for tables, listings, and figures.

 - Provide statistical consultation to clinical teams and support decision-making processes.

 - Ensure GCP compliance and high-quality standards for Alvotech's sponsored clinical trials.

 - Support internal and external resources in assay development and validation.

 - Work independently and as part of a multifunctional team to achieve project deliverables.




Job Requirements:


 - Master's Degree in a related discipline (PhD in Clinical Pharmacology or related discipline with relevant experience is desirable).

 - Minimum 10 years of experience in clinical trials or clinical pharmacology.

 - Expertise in PKPD analysis, population modelling, and simulation.

 - Experience with large molecules and biosimilars is desired.

 - Excellent written and verbal communication skills.

 - Proficiency in technical software such as Phoenix, WinNonlin, SAS, R, Monolix, and NONMEM.

 - Strong organizational and management skills.

 - Deep knowledge of ICH-GCP and regulatory guidelines.

 - Proven ability to collaborate effectively within cross-functional teams.

 - Strong interpersonal skills, including the ability to build team spirit and communicate openly.




What we offer:


 - An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.

 - The chance to be part of a global and fast-growing company.

 - An international work culture that encourages diversity, collaboration, and inclusion.

 - Positive, flexible, and innovative work environment.

 - A clear and developed organizational structure.

 - Training and global opportunities to advance.

 - A good work-life balance.

 - Home internet and home office equipment.




Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.

Active

Senior Principal Scientist - Clinical Pharmacology

Hefur &thorn;&uacute; &aacute;huga &aacute; a&eth; st&yacute;ra og hafa umsj&oacute;n me&eth; uppl&yacute;singakerfum? Alvotech leitar a&eth; metna&eth;arfullum og h&aelig;fileikar&iacute;kum IT s&eacute;rfr&aelig;&eth;ingi &iacute; greiningarvinnu til a&eth; ganga t&iacute;mabundi&eth; til li&eth;s vi&eth; uppl&yacute;singat&aelig;kniteymi sitt.

Helstu verkefni og &aacute;byrg&eth;:
<ul>
<li>Reynsla af stj&oacute;rnun og vi&eth;haldi uppl&yacute;singakerfa.</li>
<li>H&aelig;fni til a&eth; sty&eth;ja vi&eth; kerfisuppf&aelig;rslur og &uacute;rb&aelig;tur.</li>
<li>G&oacute;&eth; samskiptah&aelig;fni til a&eth; vinna me&eth; &thorn;j&oacute;nustua&eth;ilum og birgjum.</li>
<li>&THORN;ekking &aacute; n&yacute;justu t&aelig;knistefnum.</li>
<li>S&eacute;rfr&aelig;&eth;i&thorn;ekking &aacute; uppl&yacute;singakerfum.</li>
<li>F&aelig;rni til a&eth; halda verklagsreglum og ferlum uppf&aelig;r&eth;um.</li>
<li>Reynsla af ger&eth; sta&eth;la&eth;ra vinnureglna (SOPs).</li>
<li>H&aelig;fni &iacute; notenda&thorn;j&aacute;lfun og stu&eth;ningi.</li>
<li>Geta til a&eth; a&eth;sto&eth;a vi&eth; kerfispr&oacute;fanir og vottun.</li>
</ul>

H&aelig;fniskr&ouml;fur:
<ul>
<li>H&aacute;sk&oacute;lagr&aacute;&eth;a sem n&yacute;tist &iacute; starfi e&eth;a samb&aelig;rileg starfsreynsla.</li>
<li>A&eth; minnsta kosti 2 &aacute;ra reynsla &iacute; lyfjai&eth;na&eth;i.</li>
<li>&THORN;ekking &aacute; GxP reglum.</li>
<li>Reynsla af me&eth;h&ouml;ndlun t&ouml;lvukerfa.</li>
<li>&THORN;ekking &aacute; ranns&oacute;knarstofukerfum og ferlum.</li>
<li>Fram&uacute;rskarandi skrifleg og munnleg samskiptah&aelig;fni &aacute; ensku.</li>
<li>Sterk greiningarh&aelig;fni.</li>
<li>H&aelig;fni til a&eth; st&yacute;ra m&ouml;rgum verkefnum samt&iacute;mis.</li>
<li>G&oacute;&eth; skipulags- og stj&oacute;rnunarh&aelig;fni.</li>
</ul>

Overview of role:
<ul>
<li>Are you passionate about driving the life cycle management and administration of IT systems? Alvotech is looking for a passionate and skilled IT Specialist in Analytical Applications&nbsp;to temporarily join our Information Technology team.&nbsp;</li>
</ul>

Key Responsibilities:
<ul>
<li>Experience in managing and maintaining IT systems.</li>
<li>Ability to support system upgrades and improvements.</li>
<li>Good communication skills for working with vendors and service providers.</li>
<li>Knowledge of the latest technology trends.</li>
<li>Expertise in IT systems.</li>
<li>Ability to keep processes and procedures up-to-date.</li>
<li>Experience in writing Standard Operating Procedures (SOPs).</li>
<li>Skills in user training and support.</li>
<li>Ability to assist with system testing and qualification.</li>
</ul>

Qualifications:
<ul>
<li>Bachelor's degree or relevant business experience.</li>
<li>At least 2 years of experience in the Pharmaceutical or Medical Device Industry.</li>
<li>Familiarity with GxP regulatory requirements.</li>
<li>Experience in validating computer systems.</li>
<li>Knowledge of laboratory systems and processes.</li>
<li>Excellent written and verbal communication skills in English.</li>
<li>Strong analytical and interpersonal skills.</li>
<li>Ability to manage multiple tasks simultaneously.</li>
<li>Excellent organizational and management skills.</li>
</ul>

What we offer:
<ul>
<li>An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.</li>
<li>The chance to be a part of a global and fast-growing company.</li>
<li>An international work culture that encourages diversity, collaboration and inclusion.</li>
<li>Positive, flexible, and innovative work environment.</li>
<li>Support for personal growth and internal career development.</li>
<li>Company social events and milestone celebrations.</li>
<li>Excellent in-house canteen and coffee house.</li>
<li>Exercise and wellbeing support for full-time employees.</li>
<li>On-site shower facility.</li>
<li>Transportation grant towards eco-friendly modes of travel for full-time employees.</li>
<li>Internet at home for full-time employees.</li>
</ul>

Why Alvotech
At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We&rsquo;re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let&rsquo;s create a healthier world together, through affordable biologic medicines.


Hefur þú áhuga á að stýra og hafa umsjón með upplýsingakerfum? Alvotech leitar að metnaðarfullum og hæfileikaríkum IT sérfræðingi í greiningarvinnu til að ganga tímabundið til liðs við upplýsingatækniteymi sitt.



Helstu verkefni og ábyrgð:


 - Reynsla af stjórnun og viðhaldi upplýsingakerfa.

 - Hæfni til að styðja við kerfisuppfærslur og úrbætur.

 - Góð samskiptahæfni til að vinna með þjónustuaðilum og birgjum.

 - Þekking á nýjustu tæknistefnum.

 - Sérfræðiþekking á upplýsingakerfum.

 - Færni til að halda verklagsreglum og ferlum uppfærðum.

 - Reynsla af gerð staðlaðra vinnureglna (SOPs).

 - Hæfni í notendaþjálfun og stuðningi.

 - Geta til að aðstoða við kerfisprófanir og vottun.




Hæfniskröfur:


 - Háskólagráða sem nýtist í starfi eða sambærileg starfsreynsla.

 - Að minnsta kosti 2 ára reynsla í lyfjaiðnaði.

 - Þekking á GxP reglum.

 - Reynsla af meðhöndlun tölvukerfa.

 - Þekking á rannsóknarstofukerfum og ferlum.

 - Framúrskarandi skrifleg og munnleg samskiptahæfni á ensku.

 - Sterk greiningarhæfni.

 - Hæfni til að stýra mörgum verkefnum samtímis.

 - Góð skipulags- og stjórnunarhæfni.




Overview of role:


 - Are you passionate about driving the life cycle management and administration of IT systems? Alvotech is looking for a passionate and skilled IT Specialist in Analytical Applications
to temporarily join our Information Technology team.





Key Responsibilities:


 - Experience in managing and maintaining IT systems.

 - Ability to support system upgrades and improvements.

 - Good communication skills for working with vendors and service providers.

 - Knowledge of the latest technology trends.

 - Expertise in IT systems.

 - Ability to keep processes and procedures up-to-date.

 - Experience in writing Standard Operating Procedures (SOPs).

 - Skills in user training and support.

 - Ability to assist with system testing and qualification.




Qualifications:


 - Bachelor's degree or relevant business experience.

 - At least 2 years of experience in the Pharmaceutical or Medical Device Industry.

 - Familiarity with GxP regulatory requirements.

 - Experience in validating computer systems.

 - Knowledge of laboratory systems and processes.

 - Excellent written and verbal communication skills in English.

 - Strong analytical and interpersonal skills.

 - Ability to manage multiple tasks simultaneously.

 - Excellent organizational and management skills.




What we offer:


 - An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.

 - The chance to be a part of a global and fast-growing company.

 - An international work culture that encourages diversity, collaboration and inclusion.

 - Positive, flexible, and innovative work environment.

 - Support for personal growth and internal career development.

 - Company social events and milestone celebrations.

 - Excellent in-house canteen and coffee house.

 - Exercise and wellbeing support for full-time employees.

 - On-site shower facility.

 - Transportation grant towards eco-friendly modes of travel for full-time employees.

 - Internet at home for full-time employees.




Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.



True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.

IT Specialist - Analytical Applications

Overview of role
Alvotech is seeking a passionate and skilled&nbsp;Combination Product Lead&nbsp;to join our innovative&nbsp;Combination Products and Devices (CPD)&nbsp;team. The CDP team designs and develops drug delivery solutions that are reliable, accessible, and in keeping with patient needs. The Combination Product Lead works with Human Factors, Risk, Technical, and program strategy specialists to ensure the successful development, verification and validation of our products and maintenance of our combination drug product files (DHFs and DMRs).

We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website. 
We encourage you to visit our Career page (link:&nbsp;<a href="https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.alvotech.com%2Fcareers&amp;data=05%7C02%7Casgerdurj%40alvotech.com%7C1203600b68924edbbc5108dce39dd29a%7C53cf7bdbb4f949879c325764ef5621ce%7C0%7C0%7C638635514216949197%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&amp;sdata=ZppaZTohYvGV6nMErJd%2Bu4I%2FZ%2B53StVRvXZXohUtTag%3D&amp;reserved=0" target="_blank" rel="noopener">Join us - Alvotech - Better Access Better Lives</a>) It offers valuable insights into our culture, values, and the innovative work we do. 
Key Responsibilities:
<ul>
<li>Lead the compilation of DHFs, including usability files, design verification testing, and risk assessments.</li>
<li>Draft key deliverables of the design control process.</li>
<li>Collaborate with specialists to deliver design verification, validation, and risk documentation.</li>
<li>Coordinate with regulatory bodies to compile technical files for submission, ensuring compliance with MDR 2017/745 and EU Medical Devices Directive 93/42/EC.</li>
<li>Maintain technical knowledge in the function, assembly, and testing of injection devices.</li>
<li>Stay updated on regulations related to combination drug products.</li>
<li>Author sections of global submission dossiers.</li>
<li>Contribute to process improvements and SOP drafting.</li>
<li>Maintain DHF documentation with QA.</li>
<li>Coordinate document review, updates, and approval for technical projects.</li>
<li>Perform design impact assessments for proposed design changes.</li>
<li>Schedule and manage stage reviews.</li>
</ul>

Qualifications:
<ul>
<li>Master&rsquo;s Degree with a minimum of 7 years of relevant work experience.</li>
<li>Proven experience in life cycle management of combination products.</li>
<li>Strong knowledge of design control processes and regulatory requirements (ISO-13485, ISO-14971, MDR, 21 CFR part 4, ISO-11608, IEC-62366, ASTM 1980, ISO 23908 etc.)</li>
<li>Proficiency in risk management and design verification/validation (ISO-13485, ISO-14971)</li>
<li>Experience with technical documentation and regulatory submissions.</li>
<li>Excellent verbal and written English communication skills.</li>
<li>Ability to work independently and as part of a team.</li>
<li>Self-motivated, adaptable, and positive attitude.</li>
</ul>


Overview of role

Alvotech is seeking a passionate and skilled
Combination Product Lead
to join our innovative
Combination Products and Devices (CPD)
team. The CDP team designs and develops drug delivery solutions that are reliable, accessible, and in keeping with patient needs. The Combination Product Lead works with Human Factors, Risk, Technical, and program strategy specialists to ensure the successful development, verification and validation of our products and maintenance of our combination drug product files (DHFs and DMRs).



We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website.



We encourage you to visit our Career page (link:
Join us - Alvotech - Better Access Better Lives) It offers valuable insights into our culture, values, and the innovative work we do.



Key Responsibilities:


 - Lead the compilation of DHFs, including usability files, design verification testing, and risk assessments.

 - Draft key deliverables of the design control process.

 - Collaborate with specialists to deliver design verification, validation, and risk documentation.

 - Coordinate with regulatory bodies to compile technical files for submission, ensuring compliance with MDR 2017/745 and EU Medical Devices Directive 93/42/EC.

 - Maintain technical knowledge in the function, assembly, and testing of injection devices.

 - Stay updated on regulations related to combination drug products.

 - Author sections of global submission dossiers.

 - Contribute to process improvements and SOP drafting.

 - Maintain DHF documentation with QA.

 - Coordinate document review, updates, and approval for technical projects.

 - Perform design impact assessments for proposed design changes.

 - Schedule and manage stage reviews.




Qualifications:


 - Master’s Degree with a minimum of 7 years of relevant work experience.

 - Proven experience in life cycle management of combination products.

 - Strong knowledge of design control processes and regulatory requirements (ISO-13485, ISO-14971, MDR, 21 CFR part 4, ISO-11608, IEC-62366, ASTM 1980, ISO 23908 etc.)

 - Proficiency in risk management and design verification/validation (ISO-13485, ISO-14971)

 - Experience with technical documentation and regulatory submissions.

 - Excellent verbal and written English communication skills.

 - Ability to work independently and as part of a team.

 - Self-motivated, adaptable, and positive attitude.


Combination Product Lead

Overview of role:
Join Alvotech as a&nbsp;Pharmacovigilance Manager&nbsp;and become a key player in our mission to deliver safe and effective treatments to patients worldwide. In this dynamic role, you will lead and manage global pharmacovigilance activities, ensuring compliance with international safety standards and regulations. You will work cross-functionally with various departments, including Clinical Development, Patient Safety, Medical Affairs, and Regulatory Affairs, to support all safety-related activities.
Your expertise will be crucial in developing and maintaining our Global PV system, covering both post-marketing pharmacovigilance and clinical safety activities. As a Pharmacovigilance Manager, you will collaborate with internal teams and external partners to ensure the highest standards of safety and quality. This position offers an exciting opportunity to make a significant impact on patient safety and contribute to the success of Alvotech's innovative biosimilar product portfolio. 
We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website. 
We encourage you to visit our Career page (link:&nbsp;<a href="https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.alvotech.com%2Fcareers&amp;data=05%7C02%7Casgerdurj%40alvotech.com%7C1203600b68924edbbc5108dce39dd29a%7C53cf7bdbb4f949879c325764ef5621ce%7C0%7C0%7C638635514216949197%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&amp;sdata=ZppaZTohYvGV6nMErJd%2Bu4I%2FZ%2B53StVRvXZXohUtTag%3D&amp;reserved=0" target="_blank" rel="noopener">Join us - Alvotech - Better Access Better Lives</a>) It offers valuable insights into our culture, values, and the innovative work we do. 
Key Responsibilities:
<ul>
<li>Leadership in Pharmacovigilance: Oversee and engage in all PV activities within the Pharmacovigilance department.</li>
<li>Global PV System Management: Develop and manage Alvotech's Global PV system, encompassing both post-marketing and clinical safety activities.</li>
<li>Cross-Functional Collaboration: Work closely with Clinical Development, Patient Safety, Medical Affairs, and other departments to support safety-related activities.</li>
<li>Stakeholder Engagement: Collaborate with internal teams (e.g., Regulatory Affairs, Pharmaceutical Sciences) and external partners (e.g., CROs, service providers) to ensure PV compliance and performance.</li>
<li>Safety Management: Manage post-marketing PV activities for assigned products and clinical safety activities for assigned clinical study programs.</li>
<li>Comprehensive PV Activities: Oversee global pharmacovigilance tasks including ICSR/SAE processing, literature monitoring, signal management, periodic reporting, risk management, and regulatory submissions.</li>
<li>Quality and Compliance: Ensure the PV system is fully compliant with global PV and clinical safety legislation and manage PV audits and inspections.</li>
<li>Training and Development: Deliver training on pharmacovigilance processes and standards to staff and external parties.</li>
</ul>

Qualifications:
<ul>
<li>Education: Master's Degree in pharmaceutical sciences or related fields (medicine, pharmacy, life sciences).</li>
<li>Experience: Minimum of 5 years in the pharmaceutical industry with demonstrable PV knowledge. Experience with biosimilars is a strong advantage.</li>
<li>Technical Skills: Proficiency in safety databases, Microsoft Office tools, and technical software (Adobe, SharePoint, DocuSign, Veeva suite).</li>
<li>Regulatory Knowledge: Detailed understanding of PV processes, directives, regulations, and international guidelines (21CFR, GCP-R3, GVP, ICH, CIOMS etc.).</li>
<li>Communication Skills: Fluent in verbal and written English, with excellent communication and team collaboration skills.</li>
<li>Independence and Accountability: Ability to work independently, manage time effectively, and prioritize tasks.</li>
<li>Positive Work Environment: Maintain a positive, result-oriented work environment and foster a team spirit.</li>
<li>Cultural Adaptability: Ability to work in a multicultural environment and willingness to travel internationally as required.</li>
</ul>


Overview of role:

Join Alvotech as a
Pharmacovigilance Manager
and become a key player in our mission to deliver safe and effective treatments to patients worldwide. In this dynamic role, you will lead and manage global pharmacovigilance activities, ensuring compliance with international safety standards and regulations. You will work cross-functionally with various departments, including Clinical Development, Patient Safety, Medical Affairs, and Regulatory Affairs, to support all safety-related activities.

Your expertise will be crucial in developing and maintaining our Global PV system, covering both post-marketing pharmacovigilance and clinical safety activities. As a Pharmacovigilance Manager, you will collaborate with internal teams and external partners to ensure the highest standards of safety and quality. This position offers an exciting opportunity to make a significant impact on patient safety and contribute to the success of Alvotech's innovative biosimilar product portfolio.



We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website.



We encourage you to visit our Career page (link:
Join us - Alvotech - Better Access Better Lives) It offers valuable insights into our culture, values, and the innovative work we do.



Key Responsibilities:


 - Leadership in Pharmacovigilance: Oversee and engage in all PV activities within the Pharmacovigilance department.

 - Global PV System Management: Develop and manage Alvotech's Global PV system, encompassing both post-marketing and clinical safety activities.

 - Cross-Functional Collaboration: Work closely with Clinical Development, Patient Safety, Medical Affairs, and other departments to support safety-related activities.

 - Stakeholder Engagement: Collaborate with internal teams (e.g., Regulatory Affairs, Pharmaceutical Sciences) and external partners (e.g., CROs, service providers) to ensure PV compliance and performance.

 - Safety Management: Manage post-marketing PV activities for assigned products and clinical safety activities for assigned clinical study programs.

 - Comprehensive PV Activities: Oversee global pharmacovigilance tasks including ICSR/SAE processing, literature monitoring, signal management, periodic reporting, risk management, and regulatory submissions.

 - Quality and Compliance: Ensure the PV system is fully compliant with global PV and clinical safety legislation and manage PV audits and inspections.

 - Training and Development: Deliver training on pharmacovigilance processes and standards to staff and external parties.




Qualifications:


 - Education: Master's Degree in pharmaceutical sciences or related fields (medicine, pharmacy, life sciences).

 - Experience: Minimum of 5 years in the pharmaceutical industry with demonstrable PV knowledge. Experience with biosimilars is a strong advantage.

 - Technical Skills: Proficiency in safety databases, Microsoft Office tools, and technical software (Adobe, SharePoint, DocuSign, Veeva suite).

 - Regulatory Knowledge: Detailed understanding of PV processes, directives, regulations, and international guidelines (21CFR, GCP-R3, GVP, ICH, CIOMS etc.).

 - Communication Skills: Fluent in verbal and written English, with excellent communication and team collaboration skills.

 - Independence and Accountability: Ability to work independently, manage time effectively, and prioritize tasks.

 - Positive Work Environment: Maintain a positive, result-oriented work environment and foster a team spirit.

 - Cultural Adaptability: Ability to work in a multicultural environment and willingness to travel internationally as required.


Pharmacovigilance Manager

Nýjustu störfin

Helstu verkefni og &aacute;byrg&eth;:
<ul>
<li>Yfirfara lotuskr&aacute;r fyrir uppstreymi, ni&eth;urstreymi, sk&ouml;mmtun og stu&eth;p&uacute;&eth;a a&eth;ger&eth;ir.</li>
<li>Tryggja a&eth; skj&ouml;l s&eacute;u fullb&uacute;in, n&aacute;kv&aelig;m og &iacute; samr&aelig;mi vi&eth; GMP og innri g&aelig;&eth;asta&eth;la.</li>
<li>Greina og skr&aacute; fr&aacute;vik, svo sem villur e&eth;a uppl&yacute;singar sem vantar, &iacute; samr&aelig;mi vi&eth; st&ouml;&eth;lu&eth; ferli yfirfer&eth;ar lotuskr&aacute;a.</li>
<li>Vinna n&aacute;i&eth; me&eth; framlei&eth;slu, g&aelig;&eth;a- og skjaladeildum.</li>
<li>Halda n&aacute;kv&aelig;mar skr&aacute;r um yfirfarin g&ouml;gn og framvindu.</li>
<li>Veita daglegar uppf&aelig;rslur og vikulegar sk&yacute;rslur til verkefnastj&oacute;ra.</li>
</ul>

Menntunar- og h&aelig;fniskr&ouml;fur:
<ul>
<li>Menntun: Framhaldssk&oacute;lapr&oacute;f.</li>
<li>Reynsla: Ekki er ger&eth; krafa um fyrri reynslu &iacute; lyfjai&eth;na&eth;i.</li>
<li>H&aelig;fni: Fram&uacute;rskarandi skipulags- og samskiptah&aelig;fni. N&aacute;kv&aelig;m vinnubr&ouml;g&eth; og g&oacute;&eth; kunn&aacute;tta &iacute; Microsoft Office. Fram&uacute;rskarandi t&iacute;mastj&oacute;rnun og geta til a&eth; vinna sj&aacute;lfst&aelig;tt.</li>
</ul>

(English)
<ul>
<li>Review manufacturing batch records across upstream, downstream, dispensing, and buffer operations.</li>
<li>Ensure records are complete, accurate, and compliant with GMP and internal quality standards.</li>
<li>Identify and document discrepancies such as deviations, or missing information in accordance with standardized batch record review process.</li>
<li>Collaborate with manufacturing, QA, and documentation teams to resolve issues.</li>
<li>Maintain detailed logs of reviewed records and progress.</li>
<li>Provide daily updates and weekly reports to the Project Lead, DS Master Planner.</li>
</ul>

Minimum education and experience required for the role:
<ul>
<li>Education: High School Diploma</li>
<li>Experience: No prior knowledge is required.</li>
<li>Skills: Excellent written and verbal communication skills. Excellent attention to detail and good organizational skills. Proficient in use of a PC and common Microsoft packages such as Word and Excel. Ability to work independently and meet tight deadlines.</li>
</ul>

What we offer:
<ul data-offset-key="7g0o0-0-0">
<li data-block="true" data-editor="29mh2" data-offset-key="7g0o0-0-0">An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.</li>
<li data-block="true" data-editor="29mh2" data-offset-key="b09cl-0-0">The chance to be a part of a global and fast-growing company.</li>
<li data-block="true" data-editor="29mh2" data-offset-key="3l633-0-0">An international work culture that encourages diversity, collaboration and inclusion.</li>
<li data-block="true" data-editor="29mh2" data-offset-key="3f70j-0-0">Positive, flexible, and innovative work environment.</li>
<li data-block="true" data-editor="29mh2" data-offset-key="9vd1i-0-0">Excellent in-house canteen and coffee house.</li>
<li data-block="true" data-editor="29mh2" data-offset-key="diqe-0-0">On-site shower facility.</li>
</ul>

Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We&rsquo;re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let&rsquo;s create a healthier world together, through affordable biologic medicines.


Helstu verkefni og ábyrgð:


 - Yfirfara lotuskrár fyrir uppstreymi, niðurstreymi, skömmtun og stuðpúða aðgerðir.

 - Tryggja að skjöl séu fullbúin, nákvæm og í samræmi við GMP og innri gæðastaðla.

 - Greina og skrá frávik, svo sem villur eða upplýsingar sem vantar, í samræmi við stöðluð ferli yfirferðar lotuskráa.

 - Vinna náið með framleiðslu, gæða- og skjaladeildum.

 - Halda nákvæmar skrár um yfirfarin gögn og framvindu.

 - Veita daglegar uppfærslur og vikulegar skýrslur til verkefnastjóra.




Menntunar- og hæfniskröfur:


 - Menntun: Framhaldsskólapróf.

 - Reynsla: Ekki er gerð krafa um fyrri reynslu í lyfjaiðnaði.

 - Hæfni: Framúrskarandi skipulags- og samskiptahæfni. Nákvæm vinnubrögð og góð kunnátta í Microsoft Office. Framúrskarandi tímastjórnun og geta til að vinna sjálfstætt.




(English)


 - Review manufacturing batch records across upstream, downstream, dispensing, and buffer operations.

 - Ensure records are complete, accurate, and compliant with GMP and internal quality standards.

 - Identify and document discrepancies such as deviations, or missing information in accordance with standardized batch record review process.

 - Collaborate with manufacturing, QA, and documentation teams to resolve issues.

 - Maintain detailed logs of reviewed records and progress.

 - Provide daily updates and weekly reports to the Project Lead, DS Master Planner.




Minimum education and experience required for the role:


 - Education: High School Diploma

 - Experience: No prior knowledge is required.

 - Skills: Excellent written and verbal communication skills. Excellent attention to detail and good organizational skills. Proficient in use of a PC and common Microsoft packages such as Word and Excel. Ability to work independently and meet tight deadlines.




What we offer:


 - An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.

 - The chance to be a part of a global and fast-growing company.

 - An international work culture that encourages diversity, collaboration and inclusion.

 - Positive, flexible, and innovative work environment.

 - Excellent in-house canteen and coffee house.

 - On-site shower facility.




Why Alvotech



At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.



True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.

Rýni á lotuskrám / Batch Record Reviewer (Summerjob)

Alvotech is looking for a passionate and skilled Technical Investigator to become a key player in our innovative&nbsp;Combination Products and Devices (CPD) team. In this role you'll lead technical investigations, manage lab operations, and ensure the quality and reliability of our products through data analysis and problem-solving. 
We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website. 
We encourage you to visit our Career page (link:&nbsp;<a href="https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.alvotech.com%2Fcareers&amp;data=05%7C02%7Casgerdurj%40alvotech.com%7C1203600b68924edbbc5108dce39dd29a%7C53cf7bdbb4f949879c325764ef5621ce%7C0%7C0%7C638635514216949197%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&amp;sdata=ZppaZTohYvGV6nMErJd%2Bu4I%2FZ%2B53StVRvXZXohUtTag%3D&amp;reserved=0" target="_blank" rel="noopener">Join us - Alvotech - Better Access Better Lives</a>) It offers valuable insights into our culture, values, and the innovative work we do. 
Key Responsibilities:
<ul>
<li>Lead investigations and provide expert technical support within our dynamic technical team.</li>
<li>Periodically operate in R&amp;D laboratory space according to GLP principles.</li>
<li>Propose experiments and interpret data in scientifically and statistically sound manner using standard tools such as Excel, JMP, etc.</li>
<li>Interpret the impact of findings on other programs and actively support product complaint investigations.</li>
<li>Track complaint frequency, evaluate redesign proposals, and lead deviation/OOS investigations.</li>
<li>Offer specialized input into various technical investigations. </li>
</ul>
Qualifications:
<ul>
<li>Bachelor's Degree and a minimum of 5 years of relevant work experience.</li>
<li>Strong background in scientific hypothesis testing and laboratory work.</li>
<li>Excellent verbal and written English communication skills.</li>
<li>Ability to work independently and in a team setting.</li>
<li>Self-motivated, adaptable, and positive attitude.</li>
<li>Requires strong knowledge of Excel and other Microsoft suite software and preference for additional knowledge in at least one of the following: JMP, PowerBI, or Matlab/Octave.</li>
</ul>


Alvotech is looking for a passionate and skilled Technical Investigator to become a key player in our innovative
Combination Products and Devices (CPD) team. In this role you'll lead technical investigations, manage lab operations, and ensure the quality and reliability of our products through data analysis and problem-solving.



We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website.



We encourage you to visit our Career page (link:
Join us - Alvotech - Better Access Better Lives) It offers valuable insights into our culture, values, and the innovative work we do.



Key Responsibilities:


 - Lead investigations and provide expert technical support within our dynamic technical team.

 - Periodically operate in R&amp;D laboratory space according to GLP principles.

 - Propose experiments and interpret data in scientifically and statistically sound manner using standard tools such as Excel, JMP, etc.

 - Interpret the impact of findings on other programs and actively support product complaint investigations.

 - Track complaint frequency, evaluate redesign proposals, and lead deviation/OOS investigations.

 - Offer specialized input into various technical investigations.




Qualifications:


 - Bachelor's Degree and a minimum of 5 years of relevant work experience.

 - Strong background in scientific hypothesis testing and laboratory work.

 - Excellent verbal and written English communication skills.

 - Ability to work independently and in a team setting.

 - Self-motivated, adaptable, and positive attitude.

 - Requires strong knowledge of Excel and other Microsoft suite software and preference for additional knowledge in at least one of the following: JMP, PowerBI, or Matlab/Octave.


Technical Investigator

Vi&eth; leitum a&eth; lei&eth;toga &iacute;&nbsp;t&aelig;kni&thorn;j&oacute;nustuteymi&nbsp;innan lyfja og l&aelig;kningat&aelig;kja deild hj&aacute; Alvotech (e. Combination Products and Devices). Markmi&eth; deildarinnar er a&eth; &thorn;r&oacute;a v&ouml;rur (a&eth;allega lyfjapenna og sprautur) sem m&aelig;ta &thorn;&ouml;rfum notenda og au&eth;velda &thorn;eim lyfjagj&ouml;f, og standast einnig al&thorn;j&oacute;&eth;legar kr&ouml;fur um &thorn;r&oacute;un lyfja og l&aelig;kningat&aelig;kja. Markmi&eth; t&aelig;kni&thorn;j&oacute;nustuteymisins er a&eth; safna og t&uacute;lka t&aelig;knileg g&ouml;gn um v&ouml;rur &iacute; &thorn;r&oacute;un og jafnframt sty&eth;ja notkun &thorn;eirra &aacute; marka&eth;i. Lei&eth;togi t&aelig;kni&thorn;j&oacute;nustuteymisins vinnur &iacute; n&aacute;nu samstarfi vi&eth; a&eth;rar &thorn;r&oacute;unardeildir og g&aelig;&eth;asvi&eth; til a&eth; greina atvik sem koma geta upp &aacute; marka&eth;i, &thorn;j&aacute;lfa f&oacute;lk &iacute; hvernig v&ouml;rurnar virka, og lei&eth;a t&aelig;knilegar ranns&oacute;knir &thorn;egar &thorn;&ouml;rf er &aacute;. Starfi&eth; krefst reglulegrar vi&eth;veru &iacute; h&ouml;fu&eth;st&ouml;&eth;vum okkar &iacute; Reykjavik.
Vi&eth; bj&oacute;&eth;um upp &aacute; skemmtilegt og krefjandi starf &iacute; al&thorn;j&oacute;&eth;legu umhverfi &aacute;samt fj&ouml;lbreyttum t&aelig;kif&aelig;rum til starfs&thorn;r&oacute;unar. Ef &thorn;&uacute; hefur &aacute;huga &aacute; &thorn;essu spennandi t&aelig;kif&aelig;ri, hvetjum vi&eth; &thorn;ig til a&eth; kynna &thorn;&eacute;r &thorn;a&eth; betur &aacute; heimas&iacute;&eth;u okkar!&nbsp; 
Vi&eth; hvetjum &thorn;ig einnig til a&eth; sko&eth;a starfas&iacute;&eth;una okkar:&nbsp;<a href="https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.alvotech.com%2Fcareers&amp;data=05%7C02%7Casgerdurj%40alvotech.com%7C7ae86df454cf4e35e44d08dcd8068404%7C53cf7bdbb4f949879c325764ef5621ce%7C0%7C0%7C638622769693940279%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&amp;sdata=DIfyOPk%2BDLdwhPyg%2FbBK9o5hMo%2FcC0yKMZqPozqlCSQ%3D&amp;reserved=0" target="_blank" rel="noopener">Join us - Alvotech - Better Access Better Lives</a> sem veitir g&oacute;&eth;a inns&yacute;n &iacute; vinnusta&eth;amenninguna, gildin okkar og &thorn;a&eth; frumkv&ouml;&eth;la starf sem vi&eth; st&ouml;ndum fyrir. 
[English]
Overview of role:
Alvotech is seeking a&nbsp;Head of Technical Team&nbsp;to join our innovative&nbsp;Combination Products and Devices (CPD)&nbsp;team. This role is crucial for driving innovation and excellence within our technical team of four dedicated members. The purpose of this team is to provide services to the commercial organization to combination products that have graduated from development, as well as the collection of scientifically and technically sound evidence for design verification of the product during development.
The successful candidate will play a key role in overseeing laboratory setup and conducting experiments in collaboration with the Analytical &amp; Research Development lab,&nbsp;requiring frequent on-site presence&nbsp;in&nbsp;Reykjavik, Iceland.

Key Responsibilities:
<ul>
<li>Lead the CPD technical team, managing laboratory space and ensuring design verification.</li>
<li>Develop and provide training / oversee training on Alvotech products, particularly device attributes and function to stakeholders including complaint handling intake teams (internal and external), deviation investigators, QC testing teams etc.</li>
<li>Develop support service to product complaints team.</li>
<li>Develop support service for unexpected testing event / out of specification event investigations and deviations.</li>
<li>Evaluate and propose redesign opportunities and provide feedback to quality management review board.</li>
<li>Interpret impacts on other programs and support product complaint investigations.</li>
<li>Lead and provide SME input on deviation/OOS investigations.</li>
<li>Apply scientific hypothesis testing and laboratory work expertise.</li>
</ul>

Qualifications:
<ul>
<li>Master&rsquo;s Degree with at least 5 years of relevant experience.</li>
<li>Strong leadership and strategic planning skills.</li>
<li>Excellent decision-making and problem-solving abilities.</li>
<li>High level of independence and accountability.</li>
<li>Broad knowledge of the pharmaceutical value chain.</li>
<li>Experience with internal and external stakeholder engagement.</li>
<li>Ambitious, proactive, and hands-on approach.</li>
<li>Strong team player with a collaborative mindset.</li>
<li>Excellent verbal and written English communication skills.</li>
<li>Service mindset. </li>
</ul>
We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website. 
We encourage you to visit our Career page (link:&nbsp;<a href="https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.alvotech.com%2Fcareers&amp;data=05%7C02%7Casgerdurj%40alvotech.com%7C1203600b68924edbbc5108dce39dd29a%7C53cf7bdbb4f949879c325764ef5621ce%7C0%7C0%7C638635514216949197%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&amp;sdata=ZppaZTohYvGV6nMErJd%2Bu4I%2FZ%2B53StVRvXZXohUtTag%3D&amp;reserved=0" target="_blank" rel="noopener">Join us - Alvotech - Better Access Better Lives</a>) It offers valuable insights into our culture, values, and the innovative work we do.


Við leitum að leiðtoga í
tækniþjónustuteymi
innan lyfja og lækningatækja deild hjá Alvotech (e. Combination Products and Devices). Markmið deildarinnar er að þróa vörur (aðallega lyfjapenna og sprautur) sem mæta þörfum notenda og auðvelda þeim lyfjagjöf, og standast einnig alþjóðlegar kröfur um þróun lyfja og lækningatækja. Markmið tækniþjónustuteymisins er að safna og túlka tæknileg gögn um vörur í þróun og jafnframt styðja notkun þeirra á markaði. Leiðtogi tækniþjónustuteymisins vinnur í nánu samstarfi við aðrar þróunardeildir og gæðasvið til að greina atvik sem koma geta upp á markaði, þjálfa fólk í hvernig vörurnar virka, og leiða tæknilegar rannsóknir þegar þörf er á. Starfið krefst reglulegrar viðveru í höfuðstöðvum okkar í Reykjavik.

Við bjóðum upp á skemmtilegt og krefjandi starf í alþjóðlegu umhverfi ásamt fjölbreyttum tækifærum til starfsþróunar. Ef þú hefur áhuga á þessu spennandi tækifæri, hvetjum við þig til að kynna þér það betur á heimasíðu okkar!



Við hvetjum þig einnig til að skoða starfasíðuna okkar:
Join us - Alvotech - Better Access Better Lives sem veitir góða innsýn í vinnustaðamenninguna, gildin okkar og það frumkvöðla starf sem við stöndum fyrir.



[English]

Overview of role:

Alvotech is seeking a
Head of Technical Team
to join our innovative
Combination Products and Devices (CPD)
team. This role is crucial for driving innovation and excellence within our technical team of four dedicated members. The purpose of this team is to provide services to the commercial organization to combination products that have graduated from development, as well as the collection of scientifically and technically sound evidence for design verification of the product during development.

The successful candidate will play a key role in overseeing laboratory setup and conducting experiments in collaboration with the Analytical &amp; Research Development lab,
requiring frequent on-site presence
in
Reykjavik, Iceland.



Key Responsibilities:


 - Lead the CPD technical team, managing laboratory space and ensuring design verification.

 - Develop and provide training / oversee training on Alvotech products, particularly device attributes and function to stakeholders including complaint handling intake teams (internal and external), deviation investigators, QC testing teams etc.

 - Develop support service to product complaints team.

 - Develop support service for unexpected testing event / out of specification event investigations and deviations.

 - Evaluate and propose redesign opportunities and provide feedback to quality management review board.

 - Interpret impacts on other programs and support product complaint investigations.

 - Lead and provide SME input on deviation/OOS investigations.

 - Apply scientific hypothesis testing and laboratory work expertise.




Qualifications:


 - Master’s Degree with at least 5 years of relevant experience.

 - Strong leadership and strategic planning skills.

 - Excellent decision-making and problem-solving abilities.

 - High level of independence and accountability.

 - Broad knowledge of the pharmaceutical value chain.

 - Experience with internal and external stakeholder engagement.

 - Ambitious, proactive, and hands-on approach.

 - Strong team player with a collaborative mindset.

 - Excellent verbal and written English communication skills.

 - Service mindset.




We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website.



We encourage you to visit our Career page (link:
Join us - Alvotech - Better Access Better Lives) It offers valuable insights into our culture, values, and the innovative work we do.

Leiðtogi í tækniþjónustuteymi / Head of Technical Team

Reporting to QC PRI Team Leader, this is a hands-on laboratory-based position. Employee will participate in QC testing by performing ELISAs, qPCR and ligand binding assays to test for process related impurities and potency of biosimilar products produced at Alvotech.


Reporting to QC PRI Team Leader, this is a hands-on laboratory-based position. Employee will participate in QC testing by performing ELISAs, qPCR and ligand binding assays to test for process related impurities and potency of biosimilar products produced at Alvotech.

QC Bioassay Scientist - Process Related Impurity Testing

Alvotech is looking for a new member to join our amazing Quality compliance team. If you have quality compliance and risk management GxP experience in global biopharma, and you love to challenge status quo, question everything and think outside the box, then you should waste no time and check out this job at Alvotech.

This position plays a key role in driving strategic global quality compliance and risk management initiatives, with a strong focus on combination drug products. The role supports continuous improvement efforts and ensures the successful delivery of departmental objectives. Responsibilities include developing and executing a comprehensive compliance program, implementing regulatory requirements, mitigating risks, and collaborating across functions. This position reports to the Director of Combination Products &amp; Devices (CP&amp;D) Compliance and Risk Assessments.


Alvotech is looking for a new member to join our amazing Quality compliance team. If you have quality compliance and risk management GxP experience in global biopharma, and you love to challenge status quo, question everything and think outside the box, then you should waste no time and check out this job at Alvotech.



This position plays a key role in driving strategic global quality compliance and risk management initiatives, with a strong focus on combination drug products. The role supports continuous improvement efforts and ensures the successful delivery of departmental objectives. Responsibilities include developing and executing a comprehensive compliance program, implementing regulatory requirements, mitigating risks, and collaborating across functions. This position reports to the Director of Combination Products &amp; Devices (CP&amp;D) Compliance and Risk Assessments.

Compliance and Risk Management Principal Specialist

Join Alvotech as a QA Technician and play a key role in maintaining the integrity of our quality systems. This shift-based position (8-hour shifts in a 24/7 system) is ideal for detail-oriented individuals who thrive in a structured, compliance-driven environment. You&rsquo;ll be responsible for document management, record keeping, and archiving GxP documents using Veeva Vault Quality Docs. The role also involves supporting QA compliance tasks and ensuring adherence to cGMP, GDP, and Alvotech&rsquo;s QMS. A high school diploma and proficiency in Microsoft Office are required. Experience in a regulated environment is a plus.


Join Alvotech as a QA Technician and play a key role in maintaining the integrity of our quality systems. This shift-based position (8-hour shifts in a 24/7 system) is ideal for detail-oriented individuals who thrive in a structured, compliance-driven environment. You’ll be responsible for document management, record keeping, and archiving GxP documents using Veeva Vault Quality Docs. The role also involves supporting QA compliance tasks and ensuring adherence to cGMP, GDP, and Alvotech’s QMS. A high school diploma and proficiency in Microsoft Office are required. Experience in a regulated environment is a plus.

QA Technician

Join our newly formed team within the Quality division at Alvotech, a leading biosimilar pharmaceutical company. As a Specialist in Engineering &amp; CSV Compliance, you will collaborate with various departments to oversee qualification and validation activities for facilities, utilities, and equipment. You will serve as a Quality representative and subject matter expert, ensuring compliance with EU and US legislation for parenteral manufacturing. Your role will involve supporting QA oversight, reviewing and approving qualification documents, change controls, deviations, and CAPAs, and contributing to investigations and corrective actions. We seek a candidate with a bachelor's degree in a relevant area, at least 3 years of experience in the pharmaceutical or medical device industry, and a strong understanding of GAMP 5 guidelines.


Join our newly formed team within the Quality division at Alvotech, a leading biosimilar pharmaceutical company. As a Specialist in Engineering &amp; CSV Compliance, you will collaborate with various departments to oversee qualification and validation activities for facilities, utilities, and equipment. You will serve as a Quality representative and subject matter expert, ensuring compliance with EU and US legislation for parenteral manufacturing. Your role will involve supporting QA oversight, reviewing and approving qualification documents, change controls, deviations, and CAPAs, and contributing to investigations and corrective actions. We seek a candidate with a bachelor's degree in a relevant area, at least 3 years of experience in the pharmaceutical or medical device industry, and a strong understanding of GAMP 5 guidelines.