Senior Manager, QA

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 commercial activity within QA. You'll ensure compliance with regulations, industry standards, and Genmab’s Pharmaceutical Quality System. You will play a key role in overseeing commercial manufacturing activities.

The Genmab QA GMP team comprises 32 members across Denmark and the US. This role reports to the Director of QA GMP Commercial & Lifecycle, based in Denmark. This role is based in Copenhagen, Denmark, and is hybrid.

Key Responsibilities Include

• Quality Oversight of Contract Manufacturing Organizations (CMOs) in relation to GMP activities including Audits, Vendor Risk Evaluations and Quality Agreements.

• QA responsible for quality decisions in relation to batch manufacturing of Biological Intermediates (BI), Chemical Intermediates (CI) and Drug Substances (DS), in collaboration with CMOs.

• Batch Review and QP Release of BI, CI and DS.

• Gaining and maintaining knowledge on new/updated GMP-regulations and guidelines.

• Maintaining and continuously improving Genmab’s Pharmaceutical Quality System to ensure compliance with relevant regulations.

• Reviewing, authoring and approval of QMS SOPs, Work Instructions and other documents, as needed.

• Handling of Deviations, CAPAs and Change Control in compliance with Genmab SOPs and applicable regulatory requirements.

• QA representative for transfer of product from QA Late Stage to QA Commercial & Lifecycle.

• Represent GMP QA in project teams to advise on GMP compliance and execute QA activities.

• Provide/facilitate GMP training.

Requirements

• Master’s degree in a life sciences field or equivalent – must have the qualification to act as a delegated QP.

• 8+ years of QA experience in the biotech or pharmaceutical industry, with a focus on biological intermediate, chemical intermediate and drug substance is preferred.

• Experience in QA manufacturing support in relation to commercial activities.  

• 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.

• Ability to foster a culture of quality and continuous improvement within cross-functional teams and continuous improvement within cross-functional teams.

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to 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 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