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

Vi&eth; leitum a&eth; metna&eth;arfullum og reyndum v&iacute;sindamanni til a&eth; ganga til li&eth;s vi&eth; n&yacute;stofna&eth; gildingarteymi innan &thorn;r&oacute;unardeildar Alvotech (ARD). &THORN;etta er einstakt t&aelig;kif&aelig;ri til a&eth; leggja sitt af m&ouml;rkum vi&eth; &thorn;r&oacute;un l&iacute;fsb&aelig;tandi me&eth;fer&eth;a &iacute; kraftmiklu og samstilltu starfsumhverfi.

Sem v&iacute;sindama&eth;ur &iacute; gildingarteyminu munt &thorn;&uacute; gegna lykilhlutverki &iacute; a&eth; tryggja &aacute;rei&eth;anleika og reglufylgni a&eth;fer&eth;a sem nota&eth;ar eru &iacute; &thorn;r&oacute;unarverkefnum Alvotech &aacute; svi&eth;i l&iacute;fvirkra samheitalyfja. &THORN;&uacute; munt taka virkan &thorn;&aacute;tt &iacute; &ouml;llum stigum a&eth;fer&eth;agildinga, &thorn;ar &aacute; me&eth;al vi&eth; ger&eth;, yfirfer&eth; og sam&thorn;ykkt verkferla og sk&yacute;rslna, og vinna n&aacute;i&eth; me&eth; &thorn;verfaglegum teymum &aacute; bor&eth; vi&eth; g&aelig;&eth;aeftirlit (QC) og g&aelig;&eth;atryggingu (QA) til a&eth; sty&eth;ja vi&eth; flutning a&eth;fer&eth;a milli deilda og tryggja a&eth; al&thorn;j&oacute;&eth;legum g&aelig;&eth;ast&ouml;&eth;lum s&eacute; fylgt.

Starf &thorn;itt mun sty&eth;ja vi&eth; markmi&eth; Alvotech um a&eth; auka a&eth;gengi sj&uacute;klinga um allan heim a&eth; h&aacute;g&aelig;&eth;a l&iacute;ft&aelig;knilyfjahli&eth;st&aelig;&eth;um, l&aelig;kka lyfjaver&eth; og b&aelig;ta l&iacute;fsg&aelig;&eth;i &thorn;eirra.

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 h&eacute;r &aacute; heimas&iacute;&eth;u okkar.&nbsp;


[English]
We are seeking a dedicated and experienced Senior Scientist to join our newly formed Validation Team within the Analytical Research and Development (ARD) division. This is a unique opportunity to contribute to the development of life-changing therapies in a dynamic and collaborative environment.

As a Senior Scientist in the Validation Team, you will play a key role in ensuring the robustness, reliability, and regulatory compliance of analytical methods used across Alvotech&rsquo;s biosimilar development programs. You will be actively involved in multiple stages of validation activities, including protocol and report write, review and approval, and will collaborate closely with cross-functional teams such as Quality Control (QC) and Quality Assurance (QA) to support method handovers and ensure high standards of documentation and compliance.

Your work will directly support Alvotech&rsquo;s mission to deliver safe, effective, and affordable biologic medicines to patients worldwide.

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.

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.

Alvotech hf


Við leitum að metnaðarfullum og reyndum vísindamanni til að ganga til liðs við nýstofnað gildingarteymi innan þróunardeildar Alvotech (ARD). Þetta er einstakt tækifæri til að leggja sitt af mörkum við þróun lífsbætandi meðferða í kraftmiklu og samstilltu starfsumhverfi.



Sem vísindamaður í gildingarteyminu munt þú gegna lykilhlutverki í að tryggja áreiðanleika og reglufylgni aðferða sem notaðar eru í þróunarverkefnum Alvotech á sviði lífvirkra samheitalyfja. Þú munt taka virkan þátt í öllum stigum aðferðagildinga, þar á meðal við gerð, yfirferð og samþykkt verkferla og skýrslna, og vinna náið með þverfaglegum teymum á borð við gæðaeftirlit (QC) og gæðatryggingu (QA) til að styðja við flutning aðferða milli deilda og tryggja að alþjóðlegum gæðastöðlum sé fylgt.



Starf þitt mun styðja við markmið Alvotech um að auka aðgengi sjúklinga um allan heim að hágæða líftæknilyfjahliðstæðum, lækka lyfjaverð og bæta lífsgæði þeirra.



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 hér á heimasíðu okkar.






[English]

We are seeking a dedicated and experienced Senior Scientist to join our newly formed Validation Team within the Analytical Research and Development (ARD) division. This is a unique opportunity to contribute to the development of life-changing therapies in a dynamic and collaborative environment.



As a Senior Scientist in the Validation Team, you will play a key role in ensuring the robustness, reliability, and regulatory compliance of analytical methods used across Alvotech’s biosimilar development programs. You will be actively involved in multiple stages of validation activities, including protocol and report write, review and approval, and will collaborate closely with cross-functional teams such as Quality Control (QC) and Quality Assurance (QA) to support method handovers and ensure high standards of documentation and compliance.



Your work will directly support Alvotech’s mission to deliver safe, effective, and affordable biologic medicines to patients worldwide.



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.



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.

Active

Reynslumikill sérfræðingur / Senior Scientist - Validation Team (ARD)

Alvotech leitar a&eth; frams&yacute;num og reynslumiklum lei&eth;toga til a&eth; st&yacute;ra fj&ouml;lbreyttum t&aelig;kni- og verkfr&aelig;&eth;iteymum og m&oacute;ta stefnu sem sty&eth;ur vi&eth; langt&iacute;mamarkmi&eth; fyrirt&aelig;kisins &iacute; vexti og n&yacute;sk&ouml;pun. Starfi&eth; felur &iacute; s&eacute;r yfirumsj&oacute;n yfir deildir &thorn;vert &aacute; t&aelig;kni- og verkfr&aelig;&eth;isvi&eth;i. Ef &thorn;&uacute; hefur mikla t&aelig;knilega &thorn;ekkingu, sterka lei&eth;togah&aelig;fileika og reynslu af GMP-umhverfi, &thorn;&aacute; er &thorn;etta t&aelig;kif&aelig;ri&eth; fyrir &thorn;ig til a&eth; hafa raunveruleg &aacute;hrif &aacute; framt&iacute;&eth; l&iacute;ft&aelig;knilyfja.

Helstu verkefni
<ul data-offset-key="7ib0-0-0">
<li data-block="true" data-editor="1i7dq" data-offset-key="7ib0-0-0">Lei&eth;a deildir &thorn;vert &aacute; t&aelig;kni- og verkfr&aelig;&eth;isvi&eth;.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="4l2ek-0-0">Tryggja reglufylgni og &ouml;ryggi &iacute; samr&aelig;mi vi&eth; GMP og ISO.</li>
<li data-block="true" data-editor="boils" data-offset-key="20hch-0-0">Lei&eth;a n&yacute;sk&ouml;pun, stefnum&oacute;tun og umb&aelig;tur &iacute; t&aelig;kni og ferlum.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="enisf-0-0">Hafa umsj&oacute;n me&eth; ger&eth; og eftirfylgni fj&aacute;rhags&aacute;&aelig;tlana</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="1u8p9-0-0">Samskipti vi&eth; innri og ytri hagsmunaa&eth;ila.</li>
</ul>
 H&aelig;fniskr&ouml;fur
<ul data-offset-key="4e6nm-0-0">
<li data-block="true" data-editor="1i7dq" data-offset-key="4e6nm-0-0">Meistaragr&aacute;&eth;a &iacute; verkfr&aelig;&eth;i e&eth;a skyldum greinum.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="963fq-0-0">10+ &aacute;ra reynsla &iacute; lyfjai&eth;na&eth;i e&eth;a l&iacute;ft&aelig;kni.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="fmdj0-0-0">Lei&eth;togah&aelig;fni og reynsla af &thorn;v&iacute; a&eth; lei&eth;a umfangsmikil verkefni.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="7n5kc-0-0">Yfirgripsmikil &thorn;ekking &aacute; GMP og verkferlum &iacute; lyfjaframlei&eth;slu.</li>
</ul>
 [English] Alvotech is a global biopharmaceutical company dedicated to the development and manufacture of high-quality biosimilar medicines. We are seeking a visionary and experienced Head of Engineering to lead our multidisciplinary engineering teams and drive strategic initiatives that support our long-term growth and innovation goals. 
Key Responsibilities:
<ul data-offset-key="7qvls-0-0">
<li data-block="true" data-editor="fi8lk" data-offset-key="7qvls-0-0">Develop and implement engineering strategies aligned with Alvotech&rsquo;s long-term objectives.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="6v8lg-0-0">Make critical decisions in engineering to ensure sustainability and regulatory compliance.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="fssrd-0-0">Oversee departments including Maintenance, Calibration, Facility Management, Commissioning &amp; Qualification, and Process Automation.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="2jngv-0-0">Promote collaboration and operational excellence across all engineering functions.</li>
</ul>
 Role-Specific Responsibilities
<ul data-offset-key="6a0po-0-0">
<li data-block="true" data-editor="fi8lk" data-offset-key="6a0po-0-0">Oversee and coordinate technology installations to support operational and business needs.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="9tiof-0-0">Ensure compliance with GMP, ISO, and other regulatory standards.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="3qqed-0-0">Drive process optimization and technological advancement.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="eac5o-0-0">Manage stakeholder communications and regulatory interactions.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="d537-0-0">Oversee budget preparation, tracking, and cost optimization.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="9rsf-0-0">Foster a culture of growth, learning, and high performance within the engineering team.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="67vuk-0-0">10+ years of relevant experience in pharmaceutical or biotechnology industries.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="9vcn9-0-0">Proven track record in managing large-scale engineering projects and cross-functional teams.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="elfve-0-0">Strong background in GMP-compliant environments.</li>
</ul>
 Skills &amp; Competencies:
<ul data-offset-key="483d9-0-0">
<li data-block="true" data-editor="1i7dq" data-offset-key="483d9-0-0">Deep technical expertise in engineering and regulatory standards.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="cid5u-0-0">Exceptional leadership, strategic thinking, and problem-solving abilities.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="crt66-0-0">Strong financial acumen and project management skills.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="7j9p2-0-0">Excellent communication and stakeholder management capabilities.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="ai246-0-0">Adaptability to VUCA (Volatility, Uncertainty, Complexity, Ambiguity) environments.</li>
</ul>
 Certifications (Preferred):
<ul data-offset-key="3f1su-0-0">
<li data-block="true" data-editor="1i7dq" data-offset-key="3f1su-0-0">PMP or equivalent project management certification.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="19asu-0-0">Six Sigma, Lean, or other quality management certifications.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="6m34q-0-0">Leadership development and coaching training.</li>
</ul>
 Qualifications:
<ul data-offset-key="uut2-0-0">
<li data-block="true" data-editor="1i7dq" data-offset-key="uut2-0-0">Master&rsquo;s degree in Engineering (Chemical, Mechanical, Biotechnology, Pharmacy, or related field).</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="1pcbk-0-0">10+ years of relevant experience in pharmaceutical or biotechnology industries.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="46lvq-0-0">Proven track record in managing large-scale engineering projects and cross-functional teams.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="8p3g1-0-0">Strong background in GMP-compliant environments.</li>
</ul>
 What we offer:
<ul data-offset-key="8t5i-0-0">
<li data-block="true" data-editor="1i7dq" data-offset-key="8t5i-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="1i7dq" data-offset-key="5n1cs-0-0">The chance to be a part of a global and fast-growing company.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="e9fgh-0-0">An international work culture that encourages diversity, collaboration and inclusion.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="ck8v8-0-0">Positive, flexible, and innovative work environment.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="bu7u7-0-0">Support for personal growth and internal career development.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="bgg6o-0-0">Company social events and milestone celebrations.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="7t1n2-0-0">Excellent in-house canteen and coffee house.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="c675s-0-0">Exercise and wellbeing support for full-time employees.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="3kbcd-0-0">On-site shower facility.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="8mgng-0-0">Transportation grant towards eco-friendly modes of travel for full-time employees.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="eelok-0-0">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.


Alvotech leitar að framsýnum og reynslumiklum leiðtoga til að stýra fjölbreyttum tækni- og verkfræðiteymum og móta stefnu sem styður við langtímamarkmið fyrirtækisins í vexti og nýsköpun. Starfið felur í sér yfirumsjón yfir deildir þvert á tækni- og verkfræðisviði. Ef þú hefur mikla tæknilega þekkingu, sterka leiðtogahæfileika og reynslu af GMP-umhverfi, þá er þetta tækifærið fyrir þig til að hafa raunveruleg áhrif á framtíð líftæknilyfja.



Helstu verkefni


 - Leiða deildir þvert á tækni- og verkfræðisvið.

 - Tryggja reglufylgni og öryggi í samræmi við GMP og ISO.

 - Leiða nýsköpun, stefnumótun og umbætur í tækni og ferlum.

 - Hafa umsjón með gerð og eftirfylgni fjárhagsáætlana

 - Samskipti við innri og ytri hagsmunaaðila.



Hæfniskröfur


 - Meistaragráða í verkfræði eða skyldum greinum.

 - 10+ ára reynsla í lyfjaiðnaði eða líftækni.

 - Leiðtogahæfni og reynsla af því að leiða umfangsmikil verkefni.

 - Yfirgripsmikil þekking á GMP og verkferlum í lyfjaframleiðslu.




[English]

Alvotech is a global biopharmaceutical company dedicated to the development and manufacture of high-quality biosimilar medicines. We are seeking a visionary and experienced Head of Engineering to lead our multidisciplinary engineering teams and drive strategic initiatives that support our long-term growth and innovation goals.



Key Responsibilities:


 - Develop and implement engineering strategies aligned with Alvotech’s long-term objectives.

 - Make critical decisions in engineering to ensure sustainability and regulatory compliance.

 - Oversee departments including Maintenance, Calibration, Facility Management, Commissioning &amp; Qualification, and Process Automation.

 - Promote collaboration and operational excellence across all engineering functions.



Role-Specific Responsibilities


 - Oversee and coordinate technology installations to support operational and business needs.

 - Ensure compliance with GMP, ISO, and other regulatory standards.

 - Drive process optimization and technological advancement.

 - Manage stakeholder communications and regulatory interactions.

 - Oversee budget preparation, tracking, and cost optimization.

 - Foster a culture of growth, learning, and high performance within the engineering team.

 - 10+ years of relevant experience in pharmaceutical or biotechnology industries.

 - Proven track record in managing large-scale engineering projects and cross-functional teams.

 - Strong background in GMP-compliant environments.



Skills &amp; Competencies:


 - Deep technical expertise in engineering and regulatory standards.

 - Exceptional leadership, strategic thinking, and problem-solving abilities.

 - Strong financial acumen and project management skills.

 - Excellent communication and stakeholder management capabilities.

 - Adaptability to VUCA (Volatility, Uncertainty, Complexity, Ambiguity) environments.



Certifications (Preferred):


 - PMP or equivalent project management certification.

 - Six Sigma, Lean, or other quality management certifications.

 - Leadership development and coaching training.



Qualifications:


 - Master’s degree in Engineering (Chemical, Mechanical, Biotechnology, Pharmacy, or related field).

 - 10+ years of relevant experience in pharmaceutical or biotechnology industries.

 - Proven track record in managing large-scale engineering projects and cross-functional teams.

 - Strong background in GMP-compliant environments.



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.

Head of Engineering / Sviðsstjóri tækni- og verkfræðisviðs

Overview of role
Are you passionate about quality and ready to take on a key role in ensuring excellence across the lifecycle of biologic products? Alvotech is looking for a Quality Lead to join our team and serve as the single point of contact for product quality oversight from development through commercialization.
Key Responsibilities:
<ul>
<li>Act as the primary Quality representative throughout the product lifecycle&mdash;from development to discontinuation.</li>
<li>Provide expert Quality support for GMP manufacturing, product release, regulatory requirements, and clinical/commercial supply.</li>
<li>Represent Quality in internal and external program meetings, including with strategic partners and CMOs.</li>
<li>Lead or participate in Quality-to-Quality meetings with partners and CMOs.</li>
<li>Ensure timely and accurate communication of Quality deliverables to strategic partners and CMOs.</li>
<li>Review and approve Quality documentation and QMS records, including those related to tech transfers, validation, and batch documentation.</li>
<li>Support QP in compiling release documentation and APQRs.</li>
<li>Assess change controls and notify partners of changes as per Technical Quality Agreements (TQAs).</li>
<li>Contribute to the alignment of TQAs with partners and CMOs.</li>
</ul>
Qualifications:
<ul>
<li>Minimum 5 years of relevant experience in a GMP environment within the biopharmaceutical industry.</li>
<li>Deep understanding of Quality functions including QA, QC, Compliance, and Documentation.</li>
<li>Hands-on experience with QMS processes such as Deviations, Change Controls, and CAPAs.</li>
<li>Strong knowledge of global regulatory standards and expectations.</li>
<li>Familiarity with GMP-impacting systems such as Veeva, SAP, and LIMS.</li>
<li>Proven experience working with CMOs and strategic partners.</li>
<li>Skilled in remote leadership and communication.</li>
<li>Knowledge of Operational Excellence, Project Management, or Lean tools is a plus.</li>
</ul>
(Icelandic)
Ertu me&eth; brennandi &aacute;huga &aacute; g&aelig;&eth;um og tilb&uacute;in(n) a&eth; taka a&eth; &thorn;&eacute;r lykilhlutverk &iacute; a&eth; tryggja g&aelig;&eth;avottun l&iacute;ft&aelig;knilyfja fr&aacute; &thorn;r&oacute;un til marka&eth;ssetningar? Vi&eth; hj&aacute; Alvotech leitum a&eth;&nbsp;g&aelig;&eth;alei&eth;toga sem mun bera &aacute;byrg&eth; &aacute; samr&aelig;mdri g&aelig;&eth;astj&oacute;rn &iacute; gegnum allt l&iacute;ft&iacute;mabil v&ouml;runnar.
Helstu verkefni
<ul>
<li>Vera tengili&eth;ur fyrir g&aelig;&eth;am&aacute;l &iacute; &thorn;r&oacute;unar-, framlei&eth;slu- og marka&eth;sferlum l&iacute;ft&aelig;kniv&ouml;ru.</li>
<li>Veita s&eacute;rfr&aelig;&eth;ia&eth;sto&eth; vi&eth; GMP framlei&eth;slu, v&ouml;ru&uacute;tg&aacute;fu, kr&ouml;fur heilbrig&eth;isyfirvalda og kl&iacute;n&iacute;skar/marka&eth;sbirg&eth;ir.</li>
<li>Taka &thorn;&aacute;tt &iacute; innri og ytri fundum sem fulltr&uacute;i g&aelig;&eth;adeildar, m.a. me&eth; samstarfsa&eth;ilum og samningsframlei&eth;endum (CMOs).</li>
<li>St&yacute;ra e&eth;a taka &thorn;&aacute;tt &iacute; fundum um g&aelig;&eth;am&aacute;l me&eth; samstarfsa&eth;ilum og CMOs.</li>
<li>Tryggja skilvirk og r&eacute;tt samskipti um g&aelig;&eth;askj&ouml;l og afhendingar til samstarfsa&eth;ila og CMOs.</li>
<li>Sko&eth;a og sam&thorn;ykkja g&aelig;&eth;askj&ouml;l og QMS f&aelig;rslur, m.a. tengdar t&aelig;kniflutningi, sta&eth;festingarferlum og lotuskj&ouml;lum.</li>
<li>A&eth;sto&eth;a vi&eth; samantekt &uacute;tg&aacute;fuskjala og &aacute;rssk&yacute;rslna (APQR) fr&aacute; CMOs.</li>
<li>Meta breytingast&yacute;ringar og tilkynna samstarfsa&eth;ilum um breytingar &iacute; samr&aelig;mi vi&eth; TQA samninga.</li>
<li>Tryggja samr&aelig;mi &iacute; t&aelig;knilegum g&aelig;&eth;asamningum (TQA) milli Alvotech og samstarfsa&eth;ila.</li>
</ul>
H&aelig;fniskr&ouml;fur
<ul>
<li>A&eth; minnsta kosti 5 &aacute;ra reynsla &iacute; GMP umhverfi innan l&iacute;ft&aelig;knilyfjai&eth;na&eth;arins.</li>
<li>G&oacute;&eth; &thorn;ekking &aacute; g&aelig;&eth;astj&oacute;rnun, m.a. QA, QC, samr&aelig;mi og skj&ouml;lun.</li>
<li>Reynsla af QMS kerfum, m.a. fr&aacute;vikum, breytingast&yacute;ringum og CAPA ferlum.</li>
<li>&THORN;ekking &aacute; al&thorn;j&oacute;&eth;legum regluverkum og kr&ouml;fum heilbrig&eth;isyfirvalda.</li>
<li>Kunn&aacute;tta &aacute; kerfum sem hafa &aacute;hrif &aacute; GMP, t.d. Veeva, SAP og LIMS.</li>
<li>Reynsla af samskiptum vi&eth; samningsframlei&eth;endur og samstarfsa&eth;ila.</li>
<li>Lei&eth;togah&aelig;fni &iacute; fjarvinnuumhverfi.</li>
<li>&THORN;ekking &aacute; Operational Excellence, verkefnastj&oacute;rnun og/e&eth;a Lean a&eth;fer&eth;um er kostur.</li>
</ul>


Overview of role

Are you passionate about quality and ready to take on a key role in ensuring excellence across the lifecycle of biologic products? Alvotech is looking for a Quality Lead to join our team and serve as the single point of contact for product quality oversight from development through commercialization.

Key Responsibilities:


 - Act as the primary Quality representative throughout the product lifecycle—from development to discontinuation.

 - Provide expert Quality support for GMP manufacturing, product release, regulatory requirements, and clinical/commercial supply.

 - Represent Quality in internal and external program meetings, including with strategic partners and CMOs.

 - Lead or participate in Quality-to-Quality meetings with partners and CMOs.

 - Ensure timely and accurate communication of Quality deliverables to strategic partners and CMOs.

 - Review and approve Quality documentation and QMS records, including those related to tech transfers, validation, and batch documentation.

 - Support QP in compiling release documentation and APQRs.

 - Assess change controls and notify partners of changes as per Technical Quality Agreements (TQAs).

 - Contribute to the alignment of TQAs with partners and CMOs.


Qualifications:


 - Minimum 5 years of relevant experience in a GMP environment within the biopharmaceutical industry.

 - Deep understanding of Quality functions including QA, QC, Compliance, and Documentation.

 - Hands-on experience with QMS processes such as Deviations, Change Controls, and CAPAs.

 - Strong knowledge of global regulatory standards and expectations.

 - Familiarity with GMP-impacting systems such as Veeva, SAP, and LIMS.

 - Proven experience working with CMOs and strategic partners.

 - Skilled in remote leadership and communication.

 - Knowledge of Operational Excellence, Project Management, or Lean tools is a plus.


(Icelandic)

Ertu með brennandi áhuga á gæðum og tilbúin(n) að taka að þér lykilhlutverk í að tryggja gæðavottun líftæknilyfja frá þróun til markaðssetningar? Við hjá Alvotech leitum að
gæðaleiðtoga sem mun bera ábyrgð á samræmdri gæðastjórn í gegnum allt líftímabil vörunnar.

Helstu verkefni


 - Vera tengiliður fyrir gæðamál í þróunar-, framleiðslu- og markaðsferlum líftæknivöru.

 - Veita sérfræðiaðstoð við GMP framleiðslu, vöruútgáfu, kröfur heilbrigðisyfirvalda og klínískar/markaðsbirgðir.

 - Taka þátt í innri og ytri fundum sem fulltrúi gæðadeildar, m.a. með samstarfsaðilum og samningsframleiðendum (CMOs).

 - Stýra eða taka þátt í fundum um gæðamál með samstarfsaðilum og CMOs.

 - Tryggja skilvirk og rétt samskipti um gæðaskjöl og afhendingar til samstarfsaðila og CMOs.

 - Skoða og samþykkja gæðaskjöl og QMS færslur, m.a. tengdar tækniflutningi, staðfestingarferlum og lotuskjölum.

 - Aðstoða við samantekt útgáfuskjala og ársskýrslna (APQR) frá CMOs.

 - Meta breytingastýringar og tilkynna samstarfsaðilum um breytingar í samræmi við TQA samninga.

 - Tryggja samræmi í tæknilegum gæðasamningum (TQA) milli Alvotech og samstarfsaðila.


Hæfniskröfur


 - Að minnsta kosti 5 ára reynsla í GMP umhverfi innan líftæknilyfjaiðnaðarins.

 - Góð þekking á gæðastjórnun, m.a. QA, QC, samræmi og skjölun.

 - Reynsla af QMS kerfum, m.a. frávikum, breytingastýringum og CAPA ferlum.

 - Þekking á alþjóðlegum regluverkum og kröfum heilbrigðisyfirvalda.

 - Kunnátta á kerfum sem hafa áhrif á GMP, t.d. Veeva, SAP og LIMS.

 - Reynsla af samskiptum við samningsframleiðendur og samstarfsaðila.

 - Leiðtogahæfni í fjarvinnuumhverfi.

 - Þekking á Operational Excellence, verkefnastjórnun og/eða Lean aðferðum er kostur.

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.

CDMO Quality Lead / Leiðtogi í gæðamálum þróunar- og framleiðsluferla

Overview of role:
We are seeking an experienced Sterility Assurance Specialist to join our team. In this role, you will play a key part in ensuring aseptic processing and microbial control strategies across our drug substance (DS) and drug product (DP) manufacturing processes. You will provide subject matter expertise in sterility assurance, support compliance with international standards, and contribute to continuous improvement initiatives.
Key Responsibilities:
<ul>
<li>Contribute to the documentation and management of microbial control strategies from incoming goods to final product.</li>
<li>Provide oversight and sterility assurance expertise to ensure aseptic processing meets international standards.</li>
<li>Monitor facility and quality systems compliance, develop action plans to address deficiencies, and improve processes.</li>
<li>Lead and support investigations related to environmental monitoring, personnel monitoring excursions, deviations, CAPAs, and complaints.</li>
<li>Collaborate with manufacturing teams on media fill simulations, intervention monitoring, and trending.</li>
<li>Perform quality risk assessments for sterility assurance programs, including aseptic practices, environmental monitoring, sterilization, and aseptic process simulations.</li>
<li>Support internal inspections, regulatory, and client audits.</li>
<li>Author, review, and approve GMP documents such as SOPs, batch records, protocols, and reports.</li>
<li>Act as SME for deviations, CAPAs, and change controls related to sterility assurance.</li>
<li>Train, coach, and mentor less experienced staff in aseptic behaviors and cleanroom practices.</li>
<li>Ensure quality metrics and KPIs are maintained within control for areas of responsibility.</li>
</ul>
Qualifications:
<ul>
<li>Education:&nbsp;BSc degree in Pharmacy, Microbiology, or a relevant scientific discipline.</li>
<li>Experience:&nbsp;Minimum 8+ years of direct industry experience in pharmaceutical or biopharmaceutical manufacturing, with strong knowledge of cGMP standards for aseptically produced drug products.</li>
<li>Expertise in sterility assurance, contamination control strategies, and aseptic processing.</li>
<li>Strong understanding of environmental monitoring, gowning regimes, cleaning regimes, and disinfectant efficacy studies.</li>
<li>Experience with regulatory inspections and audit readiness.</li>
<li>Excellent communication, problem-solving, and leadership skills.</li>
</ul>


Overview of role:

We are seeking an experienced Sterility Assurance Specialist to join our team. In this role, you will play a key part in ensuring aseptic processing and microbial control strategies across our drug substance (DS) and drug product (DP) manufacturing processes. You will provide subject matter expertise in sterility assurance, support compliance with international standards, and contribute to continuous improvement initiatives.

Key Responsibilities:


 - Contribute to the documentation and management of microbial control strategies from incoming goods to final product.

 - Provide oversight and sterility assurance expertise to ensure aseptic processing meets international standards.

 - Monitor facility and quality systems compliance, develop action plans to address deficiencies, and improve processes.

 - Lead and support investigations related to environmental monitoring, personnel monitoring excursions, deviations, CAPAs, and complaints.

 - Collaborate with manufacturing teams on media fill simulations, intervention monitoring, and trending.

 - Perform quality risk assessments for sterility assurance programs, including aseptic practices, environmental monitoring, sterilization, and aseptic process simulations.

 - Support internal inspections, regulatory, and client audits.

 - Author, review, and approve GMP documents such as SOPs, batch records, protocols, and reports.

 - Act as SME for deviations, CAPAs, and change controls related to sterility assurance.

 - Train, coach, and mentor less experienced staff in aseptic behaviors and cleanroom practices.

 - Ensure quality metrics and KPIs are maintained within control for areas of responsibility.


Qualifications:


 - Education:
BSc degree in Pharmacy, Microbiology, or a relevant scientific discipline.

 - Experience:
Minimum 8+ years of direct industry experience in pharmaceutical or biopharmaceutical manufacturing, with strong knowledge of cGMP standards for aseptically produced drug products.

 - Expertise in sterility assurance, contamination control strategies, and aseptic processing.

 - Strong understanding of environmental monitoring, gowning regimes, cleaning regimes, and disinfectant efficacy studies.

 - Experience with regulatory inspections and audit readiness.

 - Excellent communication, problem-solving, and leadership skills.

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.