Senior GMP QA Manager (Biotechnology, Denmark)

Job summary

This role involves overseeing quality assurance for Process Performance Qualification (PPQ) and process transfers in a biotechnology setting. The position is focused on maintaining high-quality standards for both commercial and development products, requiring collaboration with internal teams and external Contract Manufacturing Organizations (CMOs).

Qualifications

• Master’s degree in life sciences or equivalent
• Minimum of 5 years of QA experience in the biotech or pharmaceutical industry
• Experience with chemical intermediates is a plus
• Hands-on experience with PPQ, process validation, and manufacturing support for late-stage or commercial products
• Strong understanding of GMP guidelines and regulatory requirements
• Experience with outsourcing and global stakeholder collaboration
• Excellent communication skills in English
• Strong organizational skills and ability to work in a fast-paced environment
• Proactive and results-driven approach with a commitment to quality

Responsibilities

• Act as QA for PPQ and process transfer activities
• Perform batch reviews of intermediates, drug substances, and drug products
• Collaborate with internal stakeholders and CMOs
• Provide QA oversight and lead CMO audits
• Represent GMP QA in global project teams
• Author SOPs and manage deviations, CAPAs, and change controls
• Ensure ongoing inspection readiness and regulatory compliance
• Facilitate GMP training
• Contribute to the continuous improvement of the Pharmaceutical Quality System

Skills

• Strong collaborative and solution-oriented mindset
• Ability to thrive in dynamic environments
• Passion for quality and continuous improvement

Education

• Master’s degree in life sciences or equivalent

Tools

• Familiarity with quality management systems and regulatory compliance tools