Senior Supplier Quality Expert

Carl Zeiss Vision, Inc.; Hebron Estates (KY); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical Vision Dental

401k Matching

Vacation and sick pay

Job summary

ZEISS Vision Care is seeking a Senior Supplier Quality Expert to ensure quality, regulatory adherence, and supplier governance for EyeCare products and supplements distributed globally. You will manage audits, CAPA, recalls, and supplier qualification, working with CDMOs and wholesale partners to maintain high standards.

The role requires extensive QA experience in regulated markets, strong leadership, and the ability to influence across functions and regulatory bodies in a hybrid work setting.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, Engineering, or related field
• Advanced GMP, GDP, or ISO 13485 Quality Management certification preferred
• 5+ years international QA experience in pharma, medical devices, or distribution
• Experience with CDMOs and collaboration partners; technical agreements
• Deep knowledge of GMP, GDP, ISO 13485, ISO 9001, ICH standards and global regs

Responsibilities

• Lead quality governance for distribution and wholesale, ensuring compliance with global standards
• Oversee supplier qualification, audits, CAPA lifecycle, and regulatory readiness
• Manage recalls, Nutrivigilance, and regulatory inspections support
• Coordinate with external partners (CDMOs, carriers, warehouses) and monitor KPIs
• Mentor quality professionals and drive process improvements and digitalization

Skills

Quality governance

Audit management

Regulatory knowledge

Leadership

Cross-functional collaboration

Education

Bachelor’s degree in a science field

Advanced GMP/GDP/ISO 13485 certs preferred

Tools

Quality Management Software

Digital tools & data analysis

Job description

About Us

About Us: How many companies can say they’ve been in business for over 177 years?! Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!

Role Overview

What’s the role? 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. Sound Interesting?

Quality Governance & Compliance

• 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.

Qualifications

• 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).

Experience & Knowledge

• 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.

Working Conditions

Global position requiring frequent international travel (up to 25%). Dynamic, cross-functional environment bridging distribution, wholesale, and client collaboration. Operates in hybrid, office, and distribution site environments. Expected to represent the organization with professionalism, resilience, and technical authority in all client and regulatory interactions.

Benefits

• Medical Vision Dental
• 401k Matching
• Employee Assistance Programs
• Vacation and sick pay
• The list goes on!

Equal Employment Opportunity

Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).

Diversity

Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age sexual orientation or identity.