Senior Manager, QA

<p><span>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.</span></p><p></p><p><br/><b>The Role &amp; Department </b><br/><br/>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.<br/><br/>The Genmab QA GMP team comprises 32 members across Denmark and the US. This role reports to the Director of QA GMP Commercial &amp; Lifecycle, based in Denmark. This role is based in Copenhagen, Denmark, and is hybrid.<br/><br/><b>Key Responsibilities Include</b></p><ul><li><p>Quality Oversight of Contract Manufacturing Organizations (CMOs) in relation to GMP activities including Audits, Vendor Risk Evaluations and Quality Agreements.</p></li><li><p>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.</p></li><li><p>Batch Review and QP Release of BI, CI and DS.</p></li><li><p>Gaining and maintaining knowledge on new/updated GMP-regulations and guidelines.</p></li><li><p>Maintaining and continuously improving Genmab’s Pharmaceutical Quality System to ensure compliance with relevant regulations.</p></li><li><p>Reviewing, authoring and approval of QMS SOPs, Work Instructions and other documents, as needed.</p></li><li><p>Handling of Deviations, CAPAs and Change Control in compliance with Genmab SOPs and applicable regulatory requirements.</p></li><li><p>QA representative for transfer of product from QA Late Stage to QA Commercial &amp; Lifecycle.</p></li><li><p>Represent GMP QA in project teams to advise on GMP compliance and execute QA activities.</p></li><li><p>Provide/facilitate GMP training.</p></li></ul><p></p><p><b>Requirements</b></p><ul><li><p>Master’s degree in a life sciences field or equivalent – must have the qualification to act as a delegated QP.</p></li><li><p>8+ years of QA experience in the biotech or pharmaceutical industry, with a focus on biological intermediate, chemical intermediate and drug substance is preferred.</p></li><li><p>Experience in QA manufacturing support in relation to commercial activities.  </p></li><li><p>QP (delegate) experience is highly desirable.</p></li><li><p>Experience in outsourcing management, audit execution, and global stakeholder collaboration are advantages.</p></li><li><p>Comprehensive understanding of GMP guidelines and relevant regulations.</p></li><li><p>Demonstrated ability to work in a fast-paced, dynamic environment.</p></li><li><p>Exceptional communication skills in English with a collaborative, solution-oriented approach.</p></li><li><p>Strong organizational skills with a commitment to meeting goals and delivering high-quality outcomes.</p></li><li><p>Ability to foster a culture of quality and continuous improvement within cross-functional teams and continuous improvement within cross-functional teams.</p></li></ul><p></p><p></p><p><b>About You</b></p><ul><li>You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment</li><li>You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving</li><li>You are a generous collaborator who can work in teams with diverse backgrounds</li><li>You are determined to do and be your best and take pride in enabling the best work of others on the team</li><li>You are not afraid to grapple with the unknown and be innovative</li><li>You have experience working in a fast-growing, dynamic company (or a strong desire to)</li><li>You work hard and are not afraid to have a little fun while you do so</li></ul><p></p><p><b>Locations</b></p><p>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.</p><p></p><p><b>About Genmab</b></p><p>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