Sr Manager, QA GMP

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

Genmab is seeking a Senior Manager for GMP QA Development - Drug Product & Clinical Supply in Denmark to set quality standards for our development products supporting Genmab's clinical pipeline and further development of commercial products.

The GMP QA Senior Manager will join the global GMP QA team, ensuring compliance with industry standards and regulations. This Denmark-based position reports to the Director of GMP QA Development - Drug Product & Clinical Supply. Our Global QA Department has over 50 GXP professionals across Denmark, the Netherlands, the US, Japan, and China.

Candidates should have strong knowledge of GMP guidelines and regulations and be interested in supporting project activities and maintaining compliance.

Key Responsibilities

The main responsibilities of the QA GMP Manager will include, but not be limited to:

• Perform batch review of Drug Product (DP) and IMP (Investigational Medicinal Product).
• Oversee and audit vendors and Contract Manufacturing Organisations (CMOs).
• Support clinical supply manufactured internally at the Genmab Site in Ballerup
• Perform audits of CMOs.
• Be the QA on UAT of IRT systems in collaboration with our digital QA team and the IRT team.
• Be the QA supporting DP, Clinical Supply on development projects.
• Manage deviations, product complaints, CAPAs, and change controls.
• Perform QA tasks relating to project needs, to support batch manufacturing and product release.
• Support audits and regulatory inspections.
• Ensure documentation and process compliance with relevant standards.
• Contribute to updates of the Pharmaceutical Quality System.
• Maintain effective relationships with internal teams and CMOs.
• Coordinate and deliver GMP training.
• Author SOPs and oversee quality-related documentation.
• Maintain compliance throughout development programmes.

In this Senior Manager role, you will work closely with your GMP QA team, your stakeholders in Technical Operations, Regulatory Affairs and CMOs on DP and IMP. This position offers a valuable opportunity to contribute to development projects within GMP QA. Genmab maintains an innovative portfolio of products designed to advance cancer therapy. There is potential for this role to progress into a Qualified Person delegate (QPd) position over time.

Requirements

• MSc or equivalent in life sciences.
• 5-10 years' pharmaceutical QA experience.
• Experience in DP and IMP for biologics or sterile products, as well as familiarity with QP‑related responsibilities, is considered highly advantageous.
• EDMS proficiency required.
• GMP lead auditor certification preferred.
• Clinical trial development and outsourcing experience desirable.
• Strong English communication and teamwork skills.
• Thrives in a fast-paced, dynamic setting.
• Results-driven and dedicated to Genmab's success.

The proposed gross annual base salary range for this position, in the primary location, based on a full time schedule is:
DKK607.920,00---911.880,00

The final salary offer will depend on several factors, including your skills, qualifications, and experience.

In addition to base salary, this position is eligible to additional forms of compensation, such as discretionary bonuses and long-term incentives.

When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to:

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs

Further details on compensation and benefits will be provided during the recruitment process.

About Genmab

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.

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 LinkedIn and X.

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

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