GMP QA Senior Manager – Process Validation

<p>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.</p><p></p><p>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.</p><p></p><p>Does this inspire you and feel like a fit? Then we would love to have you join us!</p><h2></h2><h2>The Role</h2><p>Genmab is looking for an experienced GMP QA Senior Manager to join our QA Process Validation team. In this role, you will play a key part in setting and maintaining quality standards for Process Performance Qualification (PPQ) and process transfers across both commercial and development products.</p><p>This is a senior individual contributor role with no line or people management responsibilities, offering the opportunity to work hands-on with complex, global projects.</p><p></p><p>You will become part of Genmab’s global GMP QA organization, with colleagues across Denmark, the Netherlands, the US, Japan, and China. The position is based in Denmark and reports to the Director of QA GMP Process Validation.</p><p></p><h2>Responsibilities</h2><p>As GMP QA Senior Manager, your responsibilities will include:</p><ul><li><p>Acting as QA for PPQ and process transfer activities</p></li><li><p>Performing batch review of intermediates, drug substance, and drug product</p></li><li><p>Collaborating closely with internal stakeholders and Contract Manufacturing Organizations (CMOs)</p></li><li><p>QA oversight of CMOs and leading CMO audits</p></li><li><p>Representing GMP QA in global project teams</p></li><li><p>Authoring SOPs and managing deviations, CAPAs, and change controls</p></li><li><p>Ensuring ongoing inspection readiness and regulatory compliance</p></li><li><p>Providing and facilitating GMP training</p></li><li><p>Contributing quality input to the continuous improvement of Genmab’s Pharmaceutical Quality System</p></li></ul><p></p><h2>Requirements</h2><p>To succeed in this role, you should have:</p><ul><li><p>A Master’s degree in life sciences or an equivalent qualification</p></li><li><p>At least 5 years of QA experience within the biotech or pharmaceutical industry</p></li><li><p>Experience with chemical intermediates is an advance</p></li><li><p>Hands-on experience with PPQ, process validation, manufacturing support, and process transfers for late-stage or commercial products</p></li><li><p>Strong knowledge of GMP guidelines and regulatory requirements</p></li><li><p>Experience with outsourcing, audits, and global stakeholder collaboration</p></li><li><p>Excellent communication skills in English, with a collaborative and solution-oriented mindset</p></li><li><p>Strong organizational skills and the ability to thrive in a fast-paced environment</p></li><li><p>A proactive, results-driven approach and a strong commitment to quality and continuous improvement</p></li></ul><p></p><p><b>About You</b></p><ul><li><p>You are genuinely passionate about our purpose</p></li><li><p>You bring precision and excellence to all that you do</p></li><li><p>You believe in our rooted-in-science approach to problem-solving</p></li><li><p>You are a generous collaborator who can work in teams with a broad spectrum of backgrounds</p></li><li><p>You take pride in enabling the best work of others on the team</p></li><li><p>You can grapple with the unknown and be innovative</p></li><li><p>You have experience working in a fast-growing, dynamic company (or a strong desire to)</p></li><li><p>You work hard and are not afraid to have a little fun while you do so!</p></li></ul><p></p><p><b>Locations</b></p><p>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.</p><p></p><p><b>About Genmab</b></p><p>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.</p><p></p><p>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 <a href="https://www.linkedin.com/company/genmab" target="_blank">LinkedIn</a> and <a href="https://twitter.com/Genmab" target="_blank">X</a>.</p><p></p><p>Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website <a href="https://www.genmab.com/data-privacy/job-applicant-privacy-notice" target="_blank">Job Applicant Privacy Notice (genmab.com)</a>.</p>