Senior Manager, QA GMP

Senior Manager, QA GMP

Genmab

Copenhagen, Denmark

The Role

Genmab is seeking a Senior Manager for the QA Process Validation team to set quality standards for process performance qualification (PPQ) and process transfers for our commercial and development products. The role is a senior individual contributor position with no people or line management responsibilities.

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 QA GMP Process Validation. 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.

Responsibilities

• Act as QA for PPQ and Process transfer activities
• Perform Batch Review of intermediates, drug substance and drug product
• Foster collaboration with internal stakeholders and CMOs
• Represent GMP QA in global project teams
• Oversee and audit CMOs
• Provide/facilitate GMP training
• Write SOPs and manage deviations, CAPAs, and change controls
• Ensure inspection readiness and compliance with standards and regulations
• Offer quality input and update Genmab’s Pharmaceutical Quality System

Requirements

• Master’s degree in a life sciences field or equivalent.
• 5+ years of QA experience in the biotech or pharmaceutical industry, with a focus on biologics preferred.
• Experience in manufacturing support, PPQ, and process transfer for late-stage clinical trials or commercial products.
• Experience in outsourcing management, audit execution, and global stakeholder collaboration are advantages.
• Comprehensive understanding of GMP guidelines and relevant regulations.
• Demonstrated ability to work in a fast-paced, dynamic environment.
• Exceptional communication skills in English with a collaborative, solution-oriented approach.
• Strong organizational skills with a commitment to meeting goals and delivering high-quality outcomes.
• Ability to foster a culture of quality and continuous improvement within cross-functional teams and continuous improvement within cross-functional teams.
• Result and goal orientated and committed to contributing to the overall success of Genmab.

About You

• 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!