Senior Specialist, Quality Control

Scope and Responsibilities:

• Management and oversight of individual analytical method transfers for QC, including protocol/report/gap analysis generation and implementation plans, review and approval workflows between the receiving and transferring unit.

• Participate in preparations for regulatory submissions, inspections, and responses to health authorities and/or partners for QC related activities.

• Responsible for ensuring timely completion of individual projects and assisting with establishing and maintaining departmental metrics.

• Independence in assignments and take part in small to medium departmental/cross-functional projects.

• Routinely leads projects internally and with external stakeholders

• Expert knowledge within the field of expertise such as analytical methods, techniques and equipment as well as relevant procedural/process knowledge.

• Ability to discuss challenges and communicate business critical information to supervisor or other relevant stakeholders.

Specifics of the role:

• Execution of day-to-day activities within the QC department relating to Analytical Method Transfer, Partner requests, CMO requests and Health authority related activities.

• Ensuring timely completion and support to Health Authority related activities, Partner requests and Analytical Method Transfers.

• Performs both routine tasks within procedures, processes and non-routine tasks such as identifying and/or support/lead change controls, document updates, and CAPAs.

• Management of individual Analytical Method Technology transfer/validation documentation.

• Identifying required document changes and updating of quality documentation.

• Provide technical training and support to the team as needed.

• Be aware of and comply with Alvotech’s current EHS policies.

Job requirements:

• Education: Minimum B.S in a technical discipline, (e.g., pharmacy, biotechnology, biochemistry, or a related field)

• Experience: 5+ years of experience in the pharmaceutical or biopharmaceutical industry.
• Experience in quality management system, analytical method transfers, and working cross functionally with excellent communicational skills.
• Good conceptual, problem-solving, and organizational skills – must be detail-oriented, well-organized, and able to work independently and in teams.
• Fluent command of the English language, both written and verbal.

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.

About Us

At Alvotech, we are building a global biotechnology company with a clear purpose: to expand access to high-quality, affordable biologic medicines for patients worldwide. Our people are central to that mission. Across our global teams, we bring together expertise in science, manufacturing, quality and commercial operations to shape the future of biosimilars.

We offer a dynamic, fast-moving environment where curiosity, initiative and ownership are encouraged. Rooted in Icelandic values and operating on a global stage, we value collaboration, diversity and integrity across everything we do. Our teams work on meaningful challenges, contribute directly to patient impact, and grow alongside the business.

Whether you are at the start of your career or looking to take your next step, Alvotech offers the opportunity to do work that matters, in a company driven by purpose and scale.

If you do not see a role that matches your experience today, we still welcome general applications from individuals who share our ambition and want to help improve access to biologic medicines worldwide.

If you have any technical issues, please contact: [email protected]