Head of Global Quality

About the role

ZEISS is seeking a senior leader to head the global Quality function for its Consumer Eyecare business. The role oversees quality across the United States, Europe, China and future markets, ensuring products meet all safety, regulatory and quality standards.

Key responsibilities

• Define and lead the global Quality strategy, governance and operating model for Consumer Eyecare, including internal and external manufacturing.
• Build, implement and maintain a fit‑for‑purpose global Quality Management System (QMS) across regions, product categories and manufacturing models.
• Lead local Quality teams in the US, EU and China, ensuring strong capability, clear accountability and consistent execution.
• Own global quality governance for complaints, deviations, investigations, CAPAs, change controls, recalls and management review.
• Oversee Pharmacovigilance / Post‑Market Surveillance processes, including reporting, escalation, trend monitoring and inspection readiness.
• Lead Supplier Quality and Contract Manufacturing Quality for CDMOs, contract manufacturers, packers and critical suppliers.
• Ensure compliance with regulatory frameworks such as US FDA 21 CFR Part 820, EU MDR/IVDR, ISO 13485, ISO 14971 and China NMPA requirements.

Required profile

• Senior Quality partner to the business for product launches, market expansion and supplier decisions.
• Proven experience leading global Quality organizations in regulated consumer health or medical device environments.
• Strong capability to manage cross‑functional teams across multiple regions.
• Deep understanding of regulatory requirements for consumer eyecare products, including OTC drugs and dietary supplements.

Required skills

• Knowledge of US FDA regulations (21 CFR Part 820, Part 11, OTC drug requirements, cGMP for dietary supplements).
• Familiarity with EU regulations (MDR 2017/745, IVDR 2017/746, ISO 13485, ISO 14971).
• Experience with China NMPA requirements, China GMP and local vigilance reporting.
• Expertise in Pharmacovigilance, Post‑Market Surveillance and quality risk management.
• Ability to conduct supplier and contract manufacturer qualification, audits and performance management.