Quality Manager, Regulated Consumer Health

ZEISS Group; Hebron Estates (KY); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical Vision

Dental

401k Matching

Employee Assistance Programs

Vacation and sick pay

Job summary

ZEISS is seeking a hands-on Quality Manager to support and scale our regulated consumer health portfolio, including OTC products and cosmetics. You will lead inspection-ready systems, partner with external manufacturers and 3PLs, and ensure products move safely and compliantly through warehousing, logistics, and fulfillment networks.

The ideal candidate has 5+ years in FDA-regulated QA or quality systems, strong GMP competencies, CAPA, deviations, change control, and audit readiness, with a

Qualifications

• Experience: 5+ years in Quality Assurance, Quality Systems, Supplier Quality, Regulatory Affairs, or Compliance within an FDA-regulated industry.
• Industry Context: Direct experience in OTC drugs, pharmaceuticals, sterile products, medical devices, cosmetics, personal care, or regulated consumer health products.
• Core QA Competencies: GMP quality systems knowledge 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, or outsourced manufacturers.
• Technical Review: Ability to review technical quality documentation, identify risks and gaps, and drive 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.
• 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.

Responsibilities

• Provide direct quality oversight of local warehousing, 3PL partners, distribution processes, transit temperature monitoring, and CRT storage programs.
• Maintain practical, inspection‑ready Quality Management Systems (QMS) for assigned regulated products and distribution activities; manage key QMS processes.
• Lead site readiness for FDA, customer, supplier, and internal audit activities; track quality metrics and drive continuous improvement.
• Review quality documentation including batch records, CoA, CoC, deviation summaries, sterility records, and CAPA responses; support supplier qualification and quality agreements.
• Work with Supplier Quality, Regulatory Affairs, Operations, and external manufacturers to maintain effective oversight and CAPA tracking.
• Manage product quality complaint triage, investigation, escalation, trend analysis, and timely closure; coordinate adverse event escalation with Regulatory Affairs.

Skills

Quality Assurance

GMP Systems

CAPA

Audit Readiness

Supplier Quality

Documentation

Cross-functional

Education

Bachelor's preferred

Job description

ZEISS is seeking a hands-on Quality Manager to support and scale our regulated consumer health portfolio, including OTC products and cosmetics. You will lead inspection-ready systems, partner with external manufacturers and 3PLs, and ensure products move safely and compliantly through warehousing, logistics, and fulfillment networks.

The ideal candidate has 5+ years in FDA-regulated QA or quality systems, strong GMP competencies, CAPA, deviations, change control, and audit readiness, with a