Senior Director, Head of Product Quality

About the role

AstraZeneca is looking for a Senior Director, Head of Product Quality to lead the global Product Quality organisation. You will shape how Quality supports products and clinical programmes from development through commercial supply, set the strategy, standards and capabilities, and ensure each product has one accountable Quality partner.

Key responsibilities

• Set the Product Quality strategy and transformation agenda, strengthening accountability and embedding Quality in product and programme decisions.
• Manage marketing authorisations, APQR and supply risk, liaising with Global Regulatory Affairs and resolving product-specific quality risks affecting supply or compliance.
• Ensure every product has a Product Quality Leader (PQL) or Clinical Product Quality Leader (CPQL) with clear decision rights and escalation points.
• Oversee the CPQL model from clinical supply through regulatory filings and launch readiness, and the PQL model for marketed products across sites, partners, suppliers, testing, distribution and markets.
• Provide one clear Quality position per product, including drug-device combinations, using Quality Risk Management in line with ICH Q9(R1).
• Identify recurring issues across products, sites, suppliers and markets, sponsor lifecycle product knowledge management in line with ICH Q10, and partner with Development, Manufacturing, Supply Chain, Regulatory Affairs, Medical Safety and Commercial.
• Use AI to improve product-risk assessment, ensuring AI recommendations are transparent and have a named, authorised human decision-maker.
• Maintain inspection readiness, represent Quality strategy to health authorities and auditors, and own the Product Quality budget, resources and capability plan.

Required profile

• Degree in pharmacy, science, engineering or a related discipline.
• Extensive senior leadership experience in Product Quality, CMC Quality or Quality Operations in biopharma, typically 15+ years.
• Proven success leading Quality strategy and transformation while delivering operations.
• Experience building and developing leaders across multiple sites and geographies.
• Preferred: an advanced degree (MSc, PhD or MBA); experience providing Quality input to alliance management, business development or due diligence.

Required skills

• Deep knowledge of EU and US GMP, ICH Q9(R1) and ICH Q10, and expertise in product risk, control strategies, specifications and lifecycle knowledge management.
• Credibility with health authorities such as the FDA, EMA and PMDA, including regulatory and pre-approval inspection experience.
• Practical data and AI fluency, and excellent written and verbal communication with executives and regulators.