Senior QA Manager

Senior QA Manager

Genmab

Copenhagen, Denmark

The Role & Department

With a clear strategy of becoming an integrated end-to-end biotech innovation powerhouse, Genmab recently started to market and sell their own products within cancer treatment. Expanding its focus to also being directly vested in the commercialization of the company’s products, we are now looking to further strengthen the QA Commercial & Life Cycle team located in Denmark and the United States.

As GMP QA Manager you will be a part of the well-functioning QA Commercial & Life Cycle team, with responsibility for quality oversight of Drug Products and Finished Goods for commercial products. You will have a close collaboration with our Contract Manufacturing Organizations (CMOs)/Partners and process- and QC SMEs internally at Genmab. This position will be located in DK, reporting to the Director of QA GMP Commercial & Life Cycle (located in DK).

Responsibilities & Task

• Contribute to review and release (delegated QP) of commercial products, Drug Products and Finished Goods.
• Handling of Deviations, CAPAs and Change Control in compliance with Genmab SOPs and applicable regulatory requirements.
• Providing QA oversight of contractors/vendors in relation to outsourced GMP/GDP activities including Audits, Vendor Risk Evaluations, CPV, and review and negotiation of Quality Agreements.
• Promote collaborative relations with relevant internal stakeholders, partners and CMOs.
• Supporting Quality Management Review and Annual Product Review
• Maintaining and continuously improving Genmab’s Pharmaceutical Quality System to ensure compliance with relevant guidelines and regulations.
• Gaining and maintaining knowledge on new/updated GMP regulations and guidelines.
• Reviewing and authoring of QMS SOPs, Work Instructions and template, as needed.
• Representing QA GMP in project groups to advise on GMP compliance.
• Participating in internal audits and regulatory inspections performed by various Health Authorities.
• Train QA colleagues and stakeholders in relevant GMP topics.

Requirements

• You hold a Bachelor/MSc degree or equivalent in a relevant life science subject.
• You have +5 years’ experience within the pharmaceutical industry, preferably within QA GMP/GDP.
• Experience with DP and FG GMP production and delegated QP experience
• Experience with CMO collaboration
• You have excellent interpersonal skills, problem-solving skills, communication skills in English, and a collaborative mindset.
• As a person you enjoy a fast-paced and changing environment.
• You are results and goal-oriented and committed to contributing to the overall success of Genmab.

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!