Senior Supplier Quality Expert

ZEISS•Hebron, KY

11h•Hybrid

About The Position

The Senior Supplier Quality Expert ensures the quality, compliance, and regulatory adherence of EyeCare products and nutritional supplements distributed and wholesaled by Zeiss Vision Care . This position manages strategic relationships with contract manufacturers and wholesale partners, maintaining high standards of reliability, transparency, and quality. The role serves as the principal quality and compliance gatekeeper, with independent decision-making authority over supplier qualification, audits, regulatory readiness, storage/distribution, and recall management.

Requirements

Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, Engineering, or related scientific field (Master’s preferred).
Advanced certification in GMP, GDP, or ISO 13485 Quality Management preferred (e.g., ASQ, EOQ, or equivalent).
5+ years’ experience in international quality assurance within pharmaceutical, medical device, or distribution organizations (10+ years preferred).
Demonstrated success managing complex distribution and wholesale networks and client partnerships in regulated global markets.
Expertise in supplier qualification, change control, technology transfer, regulatory inspection management, and CMC development .
Proven experience working with CDMOs and collaboration partners , including managing external alliances or technical agreements.
Deep knowledge of GMP, GDP, ISO 13485, ISO 9001, ICH Q-series standards , and global regulatory requirements; ability to translate regulations into practical, operational processes.
Strong leadership presence, strategic judgment, and integrity , with the ability to operate under pressure and influence executive-level stakeholders.
Exceptional communication skills , able to convey complex technical matters to internal teams, clients, and regulatory authorities.
High intercultural competence , capable of effectively operating in global environments; fluent in English, with German and/or Mandarin proficiency beneficial.
Proficient in quality management software, digital tools, and data analysis/reporting .

Nice To Haves

Master’s preferred
Advanced certification in GMP, GDP, or ISO 13485 Quality Management preferred (e.g., ASQ, EOQ, or equivalent).
10+ years preferred
German and/or Mandarin proficiency beneficial.

Responsibilities

Quality Governance & Compliance Lead quality governance for distribution and wholesale, ensuring compliance with EU GMP, 21 CFR 210/211/820/111, ISO 13485, EU MDR, NMPA/SAMR, EFSA, DSHEA, ICH, and other standards.
Establish and manage Quality Agreements, Technical Quality Standards, and audit frameworks with CDMOs and wholesale partners.
Evaluate, qualify, and continuously monitor contract manufacturers and wholesale partners using a risk-based approach.
Supervise GMP, GDP, and ISO 13485 audit programs, manage CAPA lifecycle, and ensure inspection readiness.
Oversee packaging, labeling, and new product launches to ensure regulatory compliance.
Recall & Safety Oversight Develop and implement recall governance processes; coordinate recalls with partners, regulatory authorities, and internal stakeholders.
Manage Nutrivigilance, safety assessment, and monitoring of dietary supplements.
Support regulatory inspections and contribute to client and authority audits as a subject matter expert.
Distribution & Wholesale Operations Oversee end-to-end distribution operations including warehousing, shipping, receiving, inventory control, and order fulfillment in DACH countries, Belgium, and France.
Ensure compliance with GDP, FDA, ISO, WHO, ICH, and other applicable standards.
Manage relationships with external partners (freight carriers, warehouse providers) and implement KPIs to monitor performance, delivery accuracy, and inventory integrity.
Ensure training and safety of warehouse staff.
Process Improvement & Digitalization Drive continuous process improvement and digitalization within the distribution and wholesale Quality Management System to enhance compliance, efficiency, and transparency.
Mentor internal quality professionals and implement training programs to elevate technical competence and inspection readiness.
Supplier & CDMO Management Lead cross-functional teams to manage the selection, contracting, onboarding, and day-to-day operations of CDMOs.
Contribute to CMC due diligence for new collaboration partners, including quality, regulatory compliance, production capacity, and technological capabilities.
Support negotiations of collaboration and technical agreements with partners.
Establish and maintain strong relationships with CDMOs and collaboration partners to ensure long-term operational excellence.
Stakeholder Collaboration Act as the key interface between internal functions (Regulatory Affairs, Supply Chain, R&D) and client representatives.
Align with client quality teams on quality systems, performance KPIs, and strategic objectives.