Head of Quality Assurance, Drug Product, GMP QA (m/f/d)

In this role you oversee the quality assurance function for internal sites and CMOs, ensuring a robust, risk-based QA system and compliant batch disposition. You lead a cross-functional QA team, drive data integrity, and partner with Regulatory Affairs, Supply Chain, and global Quality to sustain supply and patient safety. You will influence GMP readiness, CI initiatives, and the Quality Digital Roadmap across the product lifecycle. This is a strategic leadership position within the Quality organization with exposure to senior leadership and regulatory discussions.

• Lead an independent QA function (5–7 MSMQs) with authority for final batch disposition and QA oversight of manufacturing/testing
• Resolve quality issues at internal and external sites through cross-functional collaboration and escalation when needed
• Maintain full QMS compliance (CAPA, change control, data integrity) using a risk-based review approach
• Provide hands-on leadership for QA activities: complaint handling, root-cause investigations, and critical GMP issue reporting
• Oversee batch release through complex data integration and alignment with the Quality Digital Roadmap
• Drive continuous improvement to reduce deviations, shorten cycle times, and strengthen CAPA effectiveness
• Support Integrated Risk Management by identifying lifecycle risks and implementing mitigations for patient safety and efficacy
• Represent QA in internal and external leadership forums and strategic initiatives

• 10+ years in Quality Assurance or biologics manufacturing in a large multinational pharmaceutical company
• Experience managing global teams across multiple countries/time zones
• Extensive audit readiness experience (HA audits, mock audits) and risk management
• Proven QA leadership for CMOs supporting biologics manufacturing
• Expert knowledge of GMP QA requirements in a specific technical area (e.g., Formulated Bulk, Filling and Finish, packaging)
• Ability to problem-solve quality and supply issues with root cause analysis and preventive actions
• Ability to conduct knowledge transfer and build communities of practice
• Strong business-level English communication and cross-functional collaboration across regions
• Willingness to travel up to 30%
• Ability to escalate issues using sound risk judgment

• collaboration across functions
• leadership and people development
• clear communication
• GMP QA for biologics
• QA oversight of CMOs
• CAPA and change control management