GMP QA Senior Manager - Process Validation

GMP QA Senior Manager - Process Validation

Genmab

Copenhagen, Denmark

The Role

Genmab is looking for an experienced GMP QA Senior Manager to join our QA Process Validation team. In this role, you will play a key part in setting and maintaining quality standards for Process Performance Qualification (PPQ) and process transfers across both commercial and development products.

This is a senior individual contributor role with no line or people management responsibilities, offering the opportunity to work hands-on with complex, global projects.

You will become part of Genmab’s global GMP QA organization, with colleagues across Denmark, the Netherlands, the US, Japan, and China. The position is based in Denmark and reports to the Director of QA GMP Process Validation.

Responsibilities

As GMP QA Senior Manager, your responsibilities will include:

• Acting as QA for PPQ and process transfer activities
• Performing batch review of intermediates, drug substance, and drug product
• Collaborating closely with internal stakeholders and Contract Manufacturing Organizations (CMOs)
• QA oversight of CMOs and leading CMO audits
• Representing GMP QA in global project teams
• Authoring SOPs and managing deviations, CAPAs, and change controls
• Ensuring ongoing inspection readiness and regulatory compliance
• Providing and facilitating GMP training
• Contributing quality input to the continuous improvement of Genmab’s Pharmaceutical Quality System

Requirements

To succeed in this role, you should have:

• A Master’s degree in life sciences or an equivalent qualification
• At least 5 years of QA experience within the biotech or pharmaceutical industry
• Experience with chemical intermediates is an advance
• Hands-on experience with PPQ, process validation, manufacturing support, and process transfers for late-stage or commercial products
• Strong knowledge of GMP guidelines and regulatory requirements
• Experience with outsourcing, audits, and global stakeholder collaboration
• Excellent communication skills in English, with a collaborative and solution-oriented mindset
• Strong organizational skills and the ability to thrive in a fast-paced environment
• A proactive, results-driven approach and a strong commitment to quality and continuous improvement

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!