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 (Distribution & Wholesale)
Builds
Distribution and wholesale networks for EyeCare products and nutritional supplements
Domain
Medical Technology / Consumer Health / Distribution
Deliverable
client delivery
Required skills
Supplier qualification, GMP/GDP compliance, regulatory inspection management, CDMO management, recall governance, risk-based auditing, change control, technology transfer, CMC due diligence, stakeholder negotiation
Preferred skills
Advanced GMP/GDP/ISO 13485 certification, international quality assurance leadership, complex network management, digitalization of QMS
Technologies
Quality management software, data analysis tools
Responsibilities
Lead quality governance for distribution and wholesale ensuring compliance with EU GMP, 21 CFR, ISO 13485, and EU MDR; Establish and manage Quality Agreements and audit frameworks with CDMOs and wholesale partners; Develop and implement recall governance processes and manage Nutrivigilance; Oversee end-to-end distribution operations including warehousing, shipping, and inventory control in DACH, Belgium, and France; Drive continuous process improvement and digitalization within the Quality Management System; Lead cross-functional teams to manage the selection, contracting, and operations of CDMOs
Seniority
Senior, hands-on IC with strategic oversight