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Genmab
At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
The Role & Department
Genmab seeks a skilled GMP Quality Assurance (QA) Senior Manager to support clinical trial supply within QA. You'll ensure compliance with regulations, industry standards, and Genmab’s Pharmaceutical Quality System. You will play a key role in overseeing late-stage manufacturing activities.
The Genmab QA GMP team comprises 32 members across Denmark and the US. This role reports to the Director of Late Stage GMP QA, based in Denmark.
Key Responsibilities Include
QA responsible for quality decisions and batch manufacturing of intermediates and drug substances, in coordination with CMOs.
Act as QA for PPQ and process transfer.
Batch Review and Release.
Foster collaboration with internal stakeholders and CMOs.
Represent GMP QA in global project teams.
Oversee and audit CMOs.
Provide/facilitate GMP training.
Write SOPs and manage deviations, CAPAs, and change controls.
Ensure inspection readiness and compliance with standards and regulations.
Offer quality input and update Genmab’s Pharmaceutical Quality System .
Requirements
Master’s degree in a life sciences field or equivalent.
8+ years of QA experience in the biotech or pharmaceutical industry, with a focus on biologics preferred.
Experience in manufacturing support, PPQ, and process transfer for late-stage clinical trials.
QP (delegate) experience is highly desirable.
Experience in outsourcing management, audit execution, and global stakeholder collaboration are advantages.
Comprehensive understanding of GMP guidelines and relevant regulations.
Demonstrated ability to work in a fast-paced, dynamic environment.
Exceptional communication skills in English with a collaborative, solution-oriented approach.
Strong organizational skills with a commitment to meeting goals and delivering high-quality outcomes.
Experience supporting manufacturing for late-stage clinical trials, ensuring seamless transition to commercialization.
Ability to foster a culture of quality and continuous improvement within cross-functional teams and continuous improvement within cross-functional teams.
This role is based in Copenhagen, Denmark, and is hybrid.
About You
Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
