About this role
We are looking for a CMO QA Sr. Lead to join Alvotech’s Quality organization. The role is responsible for end‑to‑end Quality oversight of assigned Contract Manufacturing Organizations (CMOs), ensuring compliance with GMP requirements and supporting commercial manufacturing and product supply.
Scope & Responsibilities
Serve as the single point of contact for consistent product Quality oversight for assigned CMOs
Provide Quality support for GMP manufacturing, product release, health authority requirements, and commercial supply
Enable efficient communication and decision‑making related to Quality matters with CMOs
Ensure timely and accurate Quality communication and delivery of required documentation from CMOs
Act as Quality SME and perform review and/or approval of documents and QMS records in line with the RACI matrix
Review and/or approve documentation related to technology transfer to CMOs
Review and/or approve documentation related to commercial batches, process validation, and master batch records
Ensure QMS records related to CMOs are managed in accordance with applicable procedures
Support Alvotech and CMO Qualified Persons (QP) in compiling Quality release documentation from CMOs, as required
Support compilation and review of APQRs from CMOs as required
Review and manage CMO Technical Quality Agreements
Job Requirements
University degree in Life Sciences, Pharmacy, Engineering, or a related field
Proven experience in Quality Assurance within the pharmaceutical or biotech industry
Hands‑on experience working with or overseeing Contract Manufacturing Organizations (CMOs)
Strong knowledge of GMP, Quality Management Systems, and commercial manufacturing requirements
Experience reviewing and approving Quality documentation and agreements
Strong communication and stakeholder management skills
Highly organized, detail‑oriented, and able to work independently
Fluency in English, both written and spoken
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 well-being 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
We at Alvotech 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.
About Alvotech
Icelandic biosimilar company developing and manufacturing high-quality biologic medicines for global markets. Based in Reykjavik.
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