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, with a hands-on approach to complex global projects.

Qualifications

• Master’s degree in life sciences or equivalent
• Minimum of 5 years of QA experience in the biotech or pharmaceutical sector
• Familiarity with chemical intermediates is a plus
• Experience in PPQ, process validation, and manufacturing support for late-stage or commercial products
• Strong understanding of GMP guidelines and regulatory standards
• Background in outsourcing, audits, and collaboration with global stakeholders
• Proficient in English with excellent communication skills
• Strong organizational abilities and adaptability in a fast-paced environment
• Results-oriented with a commitment to quality and continuous improvement

Responsibilities

• Serve as QA for PPQ and process transfer activities
• Conduct batch reviews of intermediates, drug substances, and drug products
• Collaborate with internal teams and Contract Manufacturing Organizations (CMOs)
• Provide QA oversight for CMOs and lead audits
• Represent GMP QA in global project teams
• Author Standard Operating Procedures (SOPs) and manage deviations, CAPAs, and change controls
• Ensure ongoing inspection readiness and compliance with regulations
• Facilitate GMP training sessions
• Contribute to the enhancement of the Pharmaceutical Quality System

Skills

• Strong collaborative and solution-oriented mindset
• Ability to work effectively in diverse teams
• Innovative problem-solving skills
• Passion for quality and excellence in work

Education

• Master’s degree in life sciences or equivalent

Tools

• Familiarity with quality management systems and regulatory compliance tools