Head of Global Quality - #2088040

ZEISS is technology and innovation. We develop, manufacture and sell highly innovative products and solutions for our customers in a variety of business fields – always testing the limits of what is feasible.

ZEISS is an internationally leading technology enterprise operating in the optics and optoelectronics industries generating more than 11.8 billion euros in revenue with around 46,000 employees across 50 countries around the globe.

Position Summary

• Lead the global Quality function for Consumer Eyecare across the US, EU, China, and future markets
• Build, lead, and continuously improve a scalable global Quality organization covering QMS, Pharmacovigilance / Post-Market Surveillance, Supplier Quality, and Contract Manufacturing Quality
• Ensure ZEISS Consumer Eyecare products are developed, sourced, manufactured (including external/contract manufacturing), released, distributed, and monitored in line with applicable quality, safety, and regulatory requirements
• Act as the senior Quality partner to the business for launches, market expansion, supplier and contract manufacturing decisions, product changes, and quality risk management across Consumer Eyecare categories such as eye drops, eye vitamins, lid care, and other adjacent eye health products.

Responsibilities

• Define and lead the global Quality strategy, governance, and operating model for Consumer Eyecare, including external and contract manufacturing
• Build, implement, and maintain a fit-for-purpose global QMS across regions, product categories, and manufacturing models (internal and external)
• 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, non-conformances, investigations, CAPAs, change controls, recalls, and management review
• Oversee quality processes for Pharmacovigilance / vigilance / Post-Market Surveillance, including compliant reporting, escalation, trend monitoring, and inspection readiness
• Lead Supplier Quality and Contract Manufacturing Quality across CDMOs, contract manufacturers, packers, and critical suppliers
• Ensure compliance with applicable regulatory frameworks, including but not limited to: United States: U.S. Food and Drug Administration regulations (e.g., 21 CFR Part 820 (QSR), 21 CFR Part 11, OTC drug requirements, dietary supplement cGMPs); European Union: EU MDR (2017/745), IVDR (2017/746), EU GMP guidelines, ISO 13485, ISO 14971, and applicable directives for consumer health products; China: National Medical Products Administration (NMPA) requirements, China GMP, Medical Device Regulations, filing/registration requirements, and local vigilance reporting obligations
• Own supplier and contract manufacturer qualification, audits, onboarding, quality agreements, performance management, and risk-based oversight
• Ensure end-to-end quality oversight of externally manufactured products, including tech transfer, process validation, batch release governance, and ongoing performance monitoring
• Ensure readiness for internal audits, supplier audits, partner audits, and health authority inspections across all relevant markets
• Serve as the senior escalation point for critical quality issues, product quality events, serious complaints, field actions, and market actions
• Partner closely with Regulatory, Supply Chain, Procurement, Operations, R&D/Product Development, Medical/Safety, Commercial, Legal, and IT to embed quality into business processes and launch readiness
• Provide Quality leadership for new product launches, market entries, tech transfers, supplier and contract manufacturer changes, artwork or label changes, and lifecycle management
• Define and track global quality KPIs, dashboards, and management reporting, and drive continuous improvement across the function
• Support quality due diligence and risk assessment for new suppliers, contract manufacturers, partnerships, acquisitions, and future market expansions

Required Knowledge & Experience

Essential Criteria

• Degree in Pharmacy, Chemistry, Life Sciences, Engineering, or another relevant scientific discipline; advanced degree is a plus
• Proven experience in relevant Quality experience in regulated healthcare categories
• Strong experience in Consumer Healthcare / Consumer Eyecare, ideally across categories such as OTC, medical devices, pharmaceuticals, food supplements, or adjacent eye health products
• Proven leadership experience in global or multi-region Quality roles, including line management of geographically dispersed teams
• Demonstrated experience building or upgrading Quality systems in a growing international business
• Deep expertise in QMS, audits, inspections, deviations, investigations, CAPAs, change control, management review, and continuous improvement
• Strong experience in Supplier Quality and Contract Manufacturing oversight, including CDMO governance, supplier qualification, audits, and quality agreements
• Solid experience with PV / vigilance / PMS / complaint handling and post-market quality processes
• Strong understanding of regulatory and compliance requirements across the US, EU, and China, including FDA, EU MDR/IVDR, ISO standards, and NMPA frameworksStrong understanding of quality and compliance requirements across the US, EU, and China
• Experience across multiple product categories with different regulatory requirements is highly desirable
• Strong business judgment and risk-management capability, with the ability to make pragmatic decisions in a fast-moving environment
• Excellent leadership, communication, and stakeholder management skills, with the ability to influence senior cross-functional leaders in a matrix organization
• Fluent in English; additional languages, especially Mandarin and/or German, are a plus
• Willingness to travel internationally
• Strong transformational leadership with ability to operate in a matrix organization
• Hands-on mindset combined with strategic thinking
• Ability to drive change, alignment, and performance in a complex global environment