Senior Supplier Quality Expert
Core
Ensures quality, compliance, and regulatory adherence of EyeCare products and nutritional supplements distributed and wholesaled by Zeiss Vision Care.
Role type
Senior Supplier Quality Expert (Regulatory & Distribution)
Builds
Distribution and wholesale networks for EyeCare products and nutritional supplements
Domain
Medical Technology / Consumer Health / Distribution
Required skills
Supplier qualification, GMP/GDP compliance, ISO 13485 audit management, Recall governance, Nutrivigilance, CDMO management, Regulatory inspection readiness, Stakeholder collaboration, Process improvement, Data analysis
Preferred skills
Advanced GMP/GMP/ISO 13485 certification, Master's degree, 10+ years experience, German/Mandarin proficiency
Technologies
Quality management software, Digital tools
Responsibilities
Lead quality governance for distribution and wholesale ensuring compliance with EU GMP, 21 CFR, ISO 13485, EU MDR; Establish and manage Quality Agreements with CDMOs and wholesale partners; Evaluate, qualify, and continuously monitor contract manufacturers using a risk-based approach; Develop and implement recall governance processes; Oversee end-to-end distribution operations including warehousing, shipping, and inventory control in DACH, Belgium, and France; Lead cross-functional teams to manage the selection and onboarding of CDMOs; Act as the key interface between internal functions and client representatives.
Seniority
Senior, hands-on IC with strategic decision-making authority