Quality Manager, Consumer Health Products

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

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.

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?

• 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.
• 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.

We 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 day

ZEISS is an EEO/AA/M/F/Disabled Veteran Employer

Your ZEISS Recruiting Team: Christina Choing 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). Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long‑term goal of the Carl Zeiss Foundation: to bring science and society into the future together. Join us today. Inspire people tomorrow. 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.