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Open nowPosted 13 days ago

GMP QA Manager (maternity cover)

Genmab

Where
Denmark
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Your applicationOpen nowGMP QA Manager (maternity cover)Genmab · Denmark

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This job: posted 13 days ago

The posting

We are extra[not]ordinary

*(ex· tra· not· or· di· nary |\ ik-ˈstr-not-ȯr-də-ˌner-ē)

Adjective: A unique word for Genmab meaning to go way beyond what is

usual; to be remarkable; proudly unique and authentic

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JOB DESCRIPTION

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

As part of Genmab’s strategy to become an integrated end-to-end biotech innovation powerhouse, the company has expanded its focus to include commercialization and direct marketing of its own products. To ensure continued strong quality oversight during a period of parental leave, we are seeking a fixed-term GMP QA Manager (maternity cover) to join the QA Commercial & Lifecycle team until July 2027.

The role is based in Denmark and reports to the Director of QA GMP Commercial & Lifecycle. You will be part of a well-functioning and experienced team responsible for quality oversight of Drug Products (DP) and Finished Goods (FG) for commercial products, working closely with CMOs, partners, and internal SMEs.

Key Responsibilities

  • Contribute to review and release (delegated QP) of commercial Drug Products and Finished Goods
  • Handle deviations, CAPAs, and change controls in compliance with Genmab SOPs and applicable regulatory requirements
  • Provide QA oversight of contractors and vendors related to outsourced GMP activities
  • Maintain strong collaboration with internal stakeholders, partners, and CMOs
  • Support Quality Management Reviews (QMR) and Annual Product Reviews (APR)
  • Review and author QMS SOPs, work instructions, and templates as required
  • Represent QA GMP in project teams and advise on GMP compliance

Requirements

  • Bachelor’s or Master’s degree (or equivalent) in a relevant life science discipline
  • Minimum 5 years’ experience in the pharmaceutical industry, preferably within QA GMP
  • Experience with DP and FG GMP production and delegated QP responsibilities
  • Excellent communication and collaboration skills; fluent in English
  • Ability to thrive in a fast-paced and changing environment
  • Results-oriented and committed to contributing to Genmab’s overall success

The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is:

DKK563.040,00---844.560,00

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

In addition to base salary, this position is eligible for 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 eligibility for compensation and benefits based on the role 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 Job Applicant Privacy Notice (genmab.com).

Posting text belongs to the employer. Removal requests: contact us.

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