Quality Manager, Consumer Health Products
Core
Hands-on Quality Manager ensuring compliant warehousing, logistics, and fulfillment for regulated consumer health products (OTC drugs, sterile eye drops, supplements, cosmetics).
Role type
Senior IC Quality Manager (Regulated Consumer Health)
Builds
Inspection-ready quality systems and compliant distribution networks for OTC drugs, sterile products, and cosmetics.
Domain
Regulated consumer health products (OTC drugs, sterile ophthalmic products, dietary supplements, cosmetics)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP quality systems, supplier quality management, quality management systems (QMS), regulatory compliance (21 CFR 210/211, 111, MoCRA), complaint investigation, CAPA management, document control, audit readiness, temperature monitoring programs
Preferred skills
Sterile ophthalmic product experience, cold-chain distribution, CMO oversight, adverse event escalation coordination, ISO 22716 familiarity, ASQ CQA/CQM certifications
Technologies
21 CFR 210/211, 21 CFR 111, MoCRA, ISO 22716
Responsibilities
Provide direct quality oversight of local warehousing, 3PL partners, and distribution processes; Maintain practical, inspection-ready Quality Management Systems (QMS) for assigned regulated products; Manage product quality complaint triage, investigation, and adverse event escalation; Lead site readiness for FDA, customer, and internal audit activities; Review quality documentation including batch records, CoA, and sterility assurance records; Support product labeling and regulatory documentation review for OTC drugs and cosmetics
Seniority
Senior, hands-on IC
