Job Description:
How many companies can say they've been in business for over 179 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! What's the role? ZEISS is looking for a hands-on Quality Manager to help support and scale our growing regulated consumer health portfolio, including OTC sterile eye drops, dietary supplements, cosmetics, and related products. This role is ideal for a practical quality professional who enjoys building inspection-ready systems, partnering with external manufacturers and 3PLs, and ensuring products move safely and compliantly through warehousing, logistics, and fulfillment networks. This position provides critical local quality oversight over warehousing, logistics, and fulfillment operations. You will work cross-functionally with Regulatory Affairs, Supplier Quality, Operations, Customer Service, and external partners to translate regulatory expectations into clear procedures, training, and day-to-day execution. The ideal candidate has strong quality systems experience in GMP Quality, OTC drugs, pharmaceuticals, sterile products, medical devices, dietary supplements, cosmetics, personal care, or regulated consumer health products. Experience with sterile ophthalmic products is highly valuable, but candidates with strong quality systems experience in adjacent regulated environments are encouraged to apply. Sound Interesting? Here's what you'll do: Site, Warehouse & Distribution Quality Provide direct quality oversight of local warehousing, 3PL partners, distribution processes, transit temperature monitoring, and controlled room temperature (CRT) storage programs. Ensure quality expectations are clearly defined, documented, and executed across warehousing and distribution operations. Manage local quality activities related to product hold, release, rejection, escalation, and recall readiness. Partner with Operations and external logistics partners to identify quality risks, resolve issues, and drive continuous improvement.
Quality Systems & Compliance:
Maintain practical, inspection-ready Quality Management Systems (QMS) for assigned regulated products and distribution activities.
Manage key QMS processes, including document control, change control, deviations, CAPA, complaints, training, supplier quality, and recall readiness.
Help maintain compliance with applicable requirements, including 21 CFR 210/211, 21 CFR 111, cosmetic quality expectations, MoCRA-related requirements, and internal ZEISS quality standards.
Author, revise, and implement Standard Operating Procedures (SOPs), work instructions, forms, and training materials.
Lead site readiness for FDA, customer, supplier, and internal audit activities.
Track quality metrics, identify trends, and drive continuous improvement.
Product Quality, CMO & Supplier Oversight:- Review quality documentation, including batch records, Certificates of Analysis (CoA), Certificates of Conformance (CoC), deviation summaries, sterility assurance records, environmental monitoring summaries, media fill summaries, and CAPA responses, where applicable.
- Support product disposition activities by ensuring required documentation is complete, accurate, and aligned with specifications and quality agreements.
- Work with Supplier Quality, Regulatory Affairs, Operations, and external manufacturers to maintain effective CMO and supplier oversight.
- Support supplier qualification, audit readiness, audit follow-up, quality agreements, and supplier CAPA tracking.
- Resolve documentation gaps, deviations, supplier quality issues, and product quality questions through timely cross-functional follow-up. Complaints, Customer Escalations & Product Quality Investigations
- Manage product quality complaint triage, investigation, documentation, trending, and closure.
- Serve as a Tier 2 Quality escalation partner for Customer Service, Regulatory Affairs, Operations, and other internal teams. Help distinguish product quality complaints from potential adverse events or medical inquiry escalations.
- Coordinate adverse event escalation activities with Regulatory Affairs, Customer Service, designated reporting partners, and external safety resources.
- Ensure timely documentation, communication, and follow-up for complaint and safety-related escalations.
- Identify recurring complaint trends and potential quality signals requiring further investigation or escalation.
Labeling & Regulatory Support:
Support quality review of product labeling, packaging, and product documentation for OTC drugs, dietary supplements, cosmetics, and related consumer health products.
Partner with Regulatory Affairs on Drug Facts, Supplement Facts, cosmetic labeling, claims review, MoCRA-related documentation, product listings, registrations, and related regulatory activities.
Stay current on relevant FDA regulations, guidance, and industry expectations impacting OTC drugs, dietary supplements, cosmetics, and consumer health products.
Do you qualify?
Required Qualifications
Experience:
5+ years of experience in Quality Assurance, Quality Systems, Supplier Quality, Regulatory Affairs, or Compliance within an FDA-regulated industry. Industry Context: Direct experience in one or more of the following areas: OTC drugs, pharmaceuticals, sterile products, medical devices, dietary supplements, cosmetics, personal care, or regulated consumer health products.
Core QA Competencies:
Strong working knowledge of GMP quality systems, including deviations, CAPA, change control, document control, complaints, supplier quality, training, and audit readiness.
Supply Chain/Logistics Exposure: Experience working with external partners such as 3PLs, distributors, warehouses, laboratories, or outsourced manufacturers.
Technical Review: Ability to review technical quality documentation, identify risks and gaps, and drive required follow-up. Communication: Strong written and verbal communication skills with the ability to translate regulatory and quality expectations into clear procedures, training, and business processes.
Education: Bachelor's degree preferred; equivalent industry experience will be considered.
Preferred Qualifications:
Direct experience with OTC drug products, sterile ophthalmic products, controlled room temperature distribution, temperature monitoring, or cold-chain distribution models.
Familiarity with 21 CFR 210/211, 21 CFR 111, MoCRA, ISO 22716, or related distribution quality and stability standards.
Experience supporting product quality complaint investigations and coordinating adverse event escalation processes with Regulatory Affairs or external reporting partners.
Experience with CMO oversight, quality agreements, supplier audits, and supplier CAPA.Experience reviewing sterility assurance records, environmental monitoring summaries, media fill summaries, or aseptic processing documentation. ASQ CQA, ASQ CQM/OE, RAC, or related professional certification. RAC (Regulatory Affairs Certification / Training)CQA (Certified Quality Auditor by ASQ)CQM/OE (Certified Manager of Quality/Organizational Excellence)
Skills & Competencies: Practical, risk-based quality judgment.
Strong ownership and operational follow-through.
Ability to operate effectively in an outsourced manufacturing and physical distribution model.
Comfort working cross-functionally with Quality, Regulatory Affairs, Supplier Quality, Operations, Customer Service, and external logistics partners.
Strong organization and documentation discipline.
Ability to balance compliance requirements, business needs, and patient/customer protection. A continuous improvement mindset.
For candidates in New Jersey: The annual pay range for this position is $119,700 $149,600We have world class benefits to support you as an employee at ZEISS:Medical Vision Dental 401k Matching Employee Assistance Programs Vacation and sick pay from your first dayZEISS is an EEO/AA/M/F/Disabled Veteran Employer Your ZEISS Recruiting Team: Christina ChoingZeiss 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).
Summary
Location: Hebron, KY; Princeton, NJ
Type: Full time
