Senior Supplier Quality Expert

ZEISS Group; Birmingham; On-site; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Up to 25% travel

Cross-functional collaboration

Competitive compensation

10% employer pension contribution

Free ZEISS lenses

Discounted lenses for friends and/or

Job summary

ZEISS Group in Birmingham is seeking a Senior Supplier Quality Expert to lead governance for EyeCare product distribution, qualify and audit CDMOs, and ensure compliance with EU GMP, GDP, ISO 13485, EU MDR, FDA.

You will manage quality agreements, CAPA, recalls, nutrivigilance, support inspection readiness, and partner with Regulatory, Supply Chain and R&D. Requires 10+ years international QA experience and advanced degree; travel up to 25%.

Qualifications

• Master's degree or higher in a related scientific field.
• 10+ years’ international QA experience in regulated environments.
• Expertise in supplier qualification, GMP/GDP audits, and regulatory inspections.
• Experience managing CDMOs and external partners globally.
• Deep knowledge of GMP, GDP, ISO 13485, EU MDR, FDA, and ICH guidelines.

Responsibilities

• Quality governance for distribution and wholesale of EyeCare products and nutritional supplements across global markets.
• Qualifying, auditing, and managing CDMOs, contract manufacturers, and wholesale partners using a risk-based approach.
• Ensuring compliance with EU GMP, GDP, ISO 13485, EU MDR, FDA (21 CFR), ICH, EFSA, NMPA and other applicable standards.
• Overseeing Quality Agreements, audit programs, CAPA management, recall governance, and nutrivigilance processes.
• Driving inspection readiness and acting as key interface between Regulatory Affairs, Supply Chain, R&D, and external partners.
• Leading cross-functional CDMO selection, due diligence (CMC, QA, regulatory, capacity), contracting, and ongoing performance management.
• Overseeing distribution operations (warehousing, logistics, traceability, KPIs) across assigned regions.
• Driving continuous improvement and digitalization within the Quality Management System.

Skills

Supplier qualification

GMP/GDP audits

Regulatory inspections

Quality governance

Cross-functional leadership

Education

Master's degree in science

Job description

ZEISS is technology and innovation. Founded in Germany in 1846, we're 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.

As a company wholly owned by a foundation, ZEISS is rooted in and committed to responsibility in all its activities. Therefore, 15% of revenue is currently invested in science and R&D. As the pioneer of scientific optics, we continue to challenge the limits of human imagination. With our passion for excellence we create value for our customers and inspire the world to see in new ways.

Senior Supplier Quality Expert to join us in Birmingham.

Your Role

• Leading quality governance for distribution and wholesale of EyeCare products and nutritional supplements across global markets.
• Qualifying, auditing, and managing CDMOs, contract manufacturers, and wholesale partners using a risk-based approach.
• Ensuring compliance with EU GMP, GDP, ISO 13485, EU MDR, FDA (21 CFR), ICH, EFSA, NMPA and other applicable standards.
• Overseeing Quality Agreements, audit programs, CAPA management, recall governance, and nutrivigilance processes.
• Driving inspection readiness and acting as key interface between Regulatory Affairs, Supply Chain, R&D, and external partners.
• Leading cross-functional CDMO selection, due diligence (CMC, QA, regulatory, capacity), contracting, and ongoing performance management.
• Overseeing distribution operations (warehousing, logistics, traceability, KPIs) across assigned regions.
• Driving continuous improvement and digitalization within the Quality Management System.

Your Experience

• Master's degree (or higher) in Pharmacy, Chemistry, Biotechnology, Engineering, or related scientific field.
• 10+ years’ international QA experience in pharmaceutical, medical device, or regulated distribution environments.
• Strong expertise in supplier qualification, GMP/GDP audits, regulatory inspections, and technical quality agreements.
• Experience managing CDMOs and external strategic partners in global markets.
• Deep knowledge of GMP, GDP, ISO 13485, EU MDR, FDA regulations, and ICH guidelines.

You will ideally have:

• Advanced quality certifications (e.g., ASQ, EOQ or equivalent).
• Experience with nutrivigilance and dietary supplement compliance (EFSA, DSHEA).
• Executive-level communication and negotiation skills.
• Experience in digital quality systems and KPI-driven performance management.

What you'll get

• International exposure with up to 25% travel.
• Collaborative, cross-functional working environment.
• Competitive compensation and development opportunities.
• 10% employer pension contribution (providing a 4% employee contribution)
• Free ZEISS lenses for you and discounted ZEISS lenses for your friends and family