Quality Manager, Consumer Health Products

ZEISS Group•Hebron, KY

6d•Onsite

About The Position

ZEISS is seeking a hands-on Quality Manager to support and scale its growing regulated consumer health portfolio, which includes OTC sterile eye drops, dietary supplements, cosmetics, and related products. This role is designed for a practical quality professional experienced in building inspection-ready systems, collaborating with external manufacturers and 3PLs, and ensuring product safety and compliance throughout warehousing, logistics, and fulfillment. The position offers critical local quality oversight for warehousing, logistics, and fulfillment operations, requiring cross-functional collaboration with Regulatory Affairs, Supplier Quality, Operations, Customer Service, and external partners to translate regulatory expectations into actionable procedures, training, and daily execution. The ideal candidate possesses 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 valued, and candidates with robust quality systems experience in adjacent regulated fields are encouraged to apply.

Requirements

5+ years of experience in Quality Assurance, Quality Systems, Supplier Quality, Regulatory Affairs, or Compliance within an FDA-regulated industry.
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.
Strong working knowledge of GMP quality systems, including deviations, CAPA, change control, document control, complaints, supplier quality, training, and audit readiness.
Experience working with external partners such as 3PLs, distributors, warehouses, laboratories, or outsourced manufacturers.
Ability to review technical quality documentation, identify risks and gaps, and drive required follow-up.
Strong written and verbal communication skills with the ability to translate regulatory and quality expectations into clear procedures, training, and business processes.
Bachelor’s degree preferred; equivalent industry experience will be considered.
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.

Nice To Haves

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)

Responsibilities

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.
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.
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.
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.
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.