At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
The Role & Department
Genmab is seeking a GMP QA Senior Manager for Late-Stage Development QA in Denmark to set quality standards for our development products. The GMP QA Senior Manager will join the global GMP QA team, ensuring compliance with industry standards and regulations. This Denmark-based position reports to the Director of QA GMP Late-Stage Development. Our Global QA Department has over 50 GXP professionals across Denmark, the Netherlands, the US, Japan, and China.
Candidates should have strong knowledge of GMP guidelines and regulations and be interested in supporting project activities and maintaining compliance.
Key Accountabilities
The main responsibilities of the QA GMP Manager will include, but not be limited to:
- Be the QA Lead of in UAT of IRT systems and SAP in collaboration with our digital QA team and stakeholders
- Perform batch review of Drug Product (DP) and IMP (Investigational Medicinal Product)
- Oversee and audit vendors and Contract Manufacturing Organisations (CMOs).
- Manage deviations, product complaints, CAPAs, and change controls.
- Support QA for batch manufacturing and product release.
- Ensure documentation and process compliance with relevant standards.
- Contribute to updates of the Pharmaceutical Quality System.
- Maintain effective relationships with internal teams and CMOs.
- Coordinate and deliver GMP training.
- Author SOPs and oversee quality-related documentation.
- Maintain compliance throughout development programmes.
In this GMP QA Senior Manager role, you will work closely with your GMP QA team, your stakeholders in Technical Operations, Regulatory Affairs and CMOs on DP and IMP. This position offers a valuable opportunity to contribute to development projects within GMP QA. Genmab maintains an innovative portfolio of products designed to advance cancer therapy. There is potential for this role to progress into a Qualified Person delegate (QPd) position.
Skills & Experience
- MSc or equivalent in life sciences.
- 5-10 years’ pharmaceutical QA experience with system qualification
- Experience in DP and IMP for biologics or sterile products, as well as familiarity with QP‑related responsibilities, is considered highly advantageous
- EDMS proficiency required.
- GMP lead auditor certification preferred.
- Clinical trial development and outsourcing experience desirable.
- Strong English communication and teamwork skills.
- Thrives in a fast-paced, dynamic setting.
- Results-driven and dedicated to Genmab’s success.
About You
You are genuinely passionate about our purpose
You bring precision and excellence to all that you do
You believe in our rooted-in-science approach to problem-solving
You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
You take pride in enabling the best work of others on the team
You can grapple with the unknown and be innovative
You have experience working in a fast-growing, dynamic company (or a strong desire to)
You work hard and are not afraid to have a little fun while you do so!
Locations
Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our 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 to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. 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 international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.
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