GMP QA Senior Manager

At Genmab we are dedicated to building extranotordinary 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 forLate-StageDevelopment QA in Denmark to set quality standards for our development 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 andregulations andbe interested in supporting project activities andmaintainingcompliance.

Key Accountabilities

The main responsibilities of the QA GMP Manager will include but not be limited to:

• Be the QALeadofin UAT ofIRT systems and SAPin collaboration with our digital QA teamandstakeholders

• Perform batch review of Drug Product (DP) and IMP (Investigational Medicinal Product)

• Oversee and audit vendors and Contract Manufacturing Organisations (CMOs).

• Manage deviationsproductcomplaints 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 Affairsand CMOson 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 experiencewith system qualification

• Experience in DP and IMP for biologics or sterile products as well as familiarity with QPrelated responsibilities is considered highlyadvantageous

• 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 Genmabs 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 youre 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 Genmabs 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 and follow us on LinkedIn and X.

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