Senior Manager, Quality Systems
On-siteNew York, United States
Job Summary
Design, implement, and continuously improve a comprehensive Quality Management System aligned with FDA OTC requirements, cosmetic GMPs, and ISO 22716 standards. Qualify, audit, and monitor raw material suppliers, packaging vendors, and contract manufacturers while establishing performance scorecards and ensuring corrective actions are implemented. Oversee production control by verifying raw material specifications, reviewing batch records, and approving finished product testing results prior to release. Manage document control systems, lead change control processes with risk assessments, and oversee deviation, investigation, and CAPA systems. Partner cross-functionally with Innovation, Regulatory, Operations, and Supply Chain to embed quality from formula development to finished goods release. Support complaint handling, adverse event reporting, and post-market quality monitoring initiatives.
Required Qualifications
- Bachelor's degree in Chemistry, Chemical Engineering, Biology, Pharmaceutical Sciences, or related field
- 7+ years of quality experience in cosmetics, OTC, pharmaceutical, or personal care manufacturing
- Strong knowledge of FDA OTC regulations, cosmetic GMP (ISO 22716), and global regulatory frameworks
- Demonstrated experience building or significantly improving a Quality Management System
- Experience managing contract manufacturers and global suppliers
- Strong background in CAPA, root cause analysis, auditing, and risk assessment
- Experience preparing for and supporting regulatory inspections
- Covid-19 vaccination
Desired Qualifications
- Master's degree
- Bachelor's degree, English major preferred
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