Head of Product Quality
Core
Lead the global Product Quality organisation to support products and clinical programmes from development through commercial supply, ensuring integrated quality positions and risk management.
Role type
Senior leadership Product Quality Head (Biopharmaceuticals)
Builds
A predictive, trusted, and digitally enabled Quality function for medicines
Domain
Biopharmaceuticals / Clinical and Commercial Supply / Quality Operations
Required skills
Product Quality strategy, CMC Quality, Quality Operations, EU/US GMP, ICH Q9(R1), ICH Q10, product risk management, control strategies, lifecycle knowledge management, regulatory inspection readiness, AI fluency, enterprise judgement, team leadership
Preferred skills
Advanced degree (MSc/PhD/MBA) in Pharmacy/Biology/Chemistry, alliance management, business development, due diligence
Technologies
AI tools for risk assessment, digital quality systems
Responsibilities
Set Product Quality strategy and transformation agenda, manage marketing authorisations and APQR, build accountable product leadership (PQL/CPQL), lead Quality across the product lifecycle, provide integrated Product Quality positions, strengthen portfolio oversight, partner across the organisation, advance trusted use of AI, maintain inspection readiness, lead the organisation and its performance
Seniority
Principal, global leadership