Quality Manager, Consumer Health Products

About the role

ZEISS is seeking a hands-on Quality Manager to support and scale its growing regulated consumer health portfolio, including OTC sterile eye drops, dietary supplements, cosmetics, and related products.

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.
• Avoidance of repetitive tasks and responsibilities not listed above.

Requirements

• 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.
• Educational Background: Bachelor’s degree preferred; equivalent industry experience will be considered.

Qualifications

• 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.

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.
• Continuous improvement mindset.