GMP QA Manager – Fixed-Term (Denmark)

Genmab; København; On-site; DKK 563,000 - 845,000; Full time

Benefits offered by this job

Pension

Health insurance and wellness benefits

Paid time off

Employee support programs

Job summary

Genmab is seeking a fixed-term GMP QA Manager (maternity cover) to join the QA Commercial & Lifecycle team in Denmark. You will provide QA oversight of Drug Products and Finished Goods for commercial products, working with CMOs, partners and internal SMEs.

Applicants should have 5+ years in pharma QA GMP, DP/FG GMP experience and delegated QP responsibilities, with excellent communication and fluent English. This is a Denmark-based, full-time role.

Qualifications

• Bachelor’s or Master’s degree in a relevant life science discipline.
• Minimum 5 years’ experience in the pharmaceutical QA GMP field.
• 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.

Responsibilities

• Contribute to review and release (delegated QP) of commercial Drug Products and Finished Goods.
• Handle deviations, CAPAs, and change controls in line with SOPs and regulations.
• Provide QA oversight of contractors and vendors related to outsourced GMP activities.
• Maintain collaboration with internal stakeholders, partners, and CMOs.
• Support QMRs and APRs as part of Quality governance.
• Review and author QMS SOPs, work instructions, and templates as required.
• Represent QA GMP in project teams and advise on GMP compliance.

Skills

Fluent English

Excellent communication

Cross-functional collaboration

Education

Bachelor’s or Master’s degree in life sciences

Job description

Genmab is seeking a fixed-term GMP QA Manager (maternity cover) to join the QA Commercial & Lifecycle team in Denmark. You will provide QA oversight of Drug Products and Finished Goods for commercial products, working with CMOs, partners and internal SMEs.

Applicants should have 5+ years in pharma QA GMP, DP/FG GMP experience and delegated QP responsibilities, with excellent communication and fluent English. This is a Denmark-based, full-time role.