Senior Manager, QA Commercial - Drug Substance & Biological Intermediates

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.

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

The role is a senior quality specialist responsible for GMP quality oversight of commercial Drug Substance (DS) and Biological Intermediates (BI) manufactured at external Contract Manufacturing Organizations (CMOs). The role is based in Denmark and reports to the Director of QA Commercial - Drug Substance & Intermediates.

You will be part of an experienced and highly skilled QA organization, with this position holding primary accountability for Drug Substance and Biological Intermediates across commercial supply chains. The role interfaces closely with CMOs, partners, and internal subject matter experts across Quality, Regulatory Affairs, Technical Operations, and Supply Chain.

Key Responsibilities

General Compliance

• Lead QA representation for Drug Substance and Biological Intermediate in cross-functional Genmab project groups and key external collaborations, providing expert input and ensuring alignment with QA governance and regulatory expectations.
• Act as a QA subject matter expert on GMP for biologics Drug Substance and Biological Intermediates, providing expert guidance, supporting resolution of complex quality issues, and ensuring consistent application of quality standards.
• Gain and maintain expert knowledge of applicable GMP legislation, guidelines, and industry practices relevant to DS and BI manufacturing; assess relevance for Genmab activities and ensure structured dissemination of applicable updates to relevant stakeholders.
• Lead the resolution of DS- and BI-related quality issues in collaboration with internal and external stakeholders, escalating critical or high-risk matters as appropriate to ensure timely and compliant decision-making.

• Continuously improving PQS: Participate in developing, maintaining, and continuously improving Genmab's Pharmaceutical Quality System (PQS) in alignment with applicable GMP and GDP requirements.
• Quality Risk Management: Apply and support quality risk management principles in complex PQS activities, providing expert input to risk assessments and mitigation actions.
• Procedures: Review/authoring and approval of SOPs, Work Instructions, templates and forms within assigned areas, and support document updates in accordance with the PQS.
• Deviation, CAPA, Change Control: Handle and support deviations, CAPAs and change controls, providing expert input and ensuring compliance with procedures and applicable regulatory requirements.
• Inspections & Audits: Participate in audits and inspections performed by national authorities and internal or external auditors as required. Support audit and inspection readiness by ensuring documentation, procedures and processes within assigned scope are maintained in compliance with company standards and applicable regulations. Support audit and inspection preparation and conduct through back-office activities, documentation and presentation support.
• QMR: Provide expert input to Quality Management Reviews (QMRs) as part of the PQS, contributing to data analysis, trend interpretation and identification of quality risks and improvement opportunities.
• Complaints & Recalls: Handle and support complex product complaints and recall-related activities as part of the PQS, providing expert input to investigations, risk assessments and corrective actions in compliance with procedures and regulatory requirements.
• Batch Review & Release: Perform batch review and batch release activities and act as delegated QP and ensure compliance with approved procedures and regulatory requirements.
• CPV: Support, review and approve Continued Process Verification (CPV) activities as part of the PQS, providing expert input to data analysis, trend evaluation and identification of potential process risks in compliance with regulatory requirements.
• APQR: Prepare, review and support complex Annual Product Quality Reviews (APQRs) as part of the PQS, providing expert input to data analysis, trend evaluation and conclusions in compliance with regulatory requirements.
• Training: Provide expert training in complex or specialized quality topics as defined by QA, supporting consistent understanding and application of quality requirements.

• Provide expert and operational supplier quality oversight for Drug Substance and Biological Intermediate manufacturers, including supplier audits, vendor risk evaluations, Quality Agreements, supplier meetings, and external notifications.
• Provide expert input to the resolution of complex DS- and BI-related supplier quality issues, ensuring compliance with regulatory requirements and Genmab quality standards.

• Bachelor's or Master's degree (or equivalent) in a relevant life science discipline.
• Solid experience (5 years) within pharmaceutical QA GMP, preferably related to Drug Substance and Intermediates.
• Experience with outsourced manufacturing and delegated QP responsibilities.
• Strong communication and collaboration skills; fluent in English.
• Ability to work independently in a complex and fast-paced environment.
• Ability to thrive in a fast-paced and changing environment
• Results-oriented and committed to contributing to Genmab's overall success

• 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!