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.