Alvotech hf

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.

Vinnustaðurinn

Compliance and Risk Management Principal Specialist

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 & Devices (CP&D) Compliance and Risk Assessments.

Helstu verkefni og ábyrgð

Develop, implement, and maintain global compliance and risk management programs.
Execute key activities related to quality compliance and risk management, particularly for combination drug products.
Creation and maintenance of documentation related to quality compliance and risk management.
Provide subject matter expertise to ensure adherence to regulatory and internal standards.
Conduct risk assessments to identify, evaluate, and mitigate risks.
Conduct regular reviews and investigations to identify potential compliance risks and ensure corrective actions are taken.
Manage compliance and risk management deviations, audit or inspection findings, investigations, and associated CAPAs, providing resolutions.
Engage in quality-related continuous improvement projects.
Collaborate with cross-functional teams including Manufacturing, Quality Control, Quality Assurance, R&D, and Regulatory Affairs to address compliance and risk-related matters.
Facilitate effective communication and decision-making on compliance and risk topics.
Contribute to inspection readiness and support inspection activities as defined.
Participate in internal and external audits.
Manage deviations, audit/inspection findings, investigations, and associated CAPAs, including resolution development.

Menntunar- og hæfniskröfur

Bachelor’s or master’s degree in a relevant scientific or engineering discipline (e.g., Biology, Biochemistry, Pharmacy, Chemistry, Chemical Engineering, Microbiology).
Minimum of 5 years of relevant experience in the biopharmaceutical or pharmaceutical industry.
Strong knowledge of international GMP standards and regulations (e.g., CFR, EMA, PIC/S, ICH, ISO 13485).
Proficiency with modern IT systems.
Project management skills with the ability to lead and manage multiple complex projects.
Excellent communication and presentation skills.
Fluent in English, both written and verbal.
Prior experience with combination drug products is a plus.