Job Description
Director of Quality – Manufacturing
We are seeking an experienced Director of Quality to lead company-wide Quality Assurance, Quality Control, Validation, and FDA compliance functions. This role has high visibility, significant influence, and full authority over product disposition and quality system governance.
Key Responsibilities
- Lead QA, QC, Validation, and compliance teams; oversee QMS effectiveness and continuous improvement.
- Ensure full compliance with FDA regulations, cGMP, OTC monographs, and internal standards.
- Serve as primary Quality representative during FDA inspections and external audits.
- Oversee batch record review, deviations, CAPA, complaints, supplier qualification, and validation programs.
- Partner with Operations and R&D to support efficient manufacturing, new product launches, and technical transfers.
- Develop KPIs, manage risk, and communicate quality issues and mitigation strategies to leadership.
- Manage, mentor, and develop Quality supervisors and managers.
Qualifications
- Bachelor’s degree in a scientific or technical field (advanced degree preferred).
- 7–10 years of progressive Quality leadership in regulated OTC or pharmaceutical manufacturing.
- 5+ years managing leaders or supervisors in a cGMP environment.
- Proven experience leading FDA inspections and drafting regulatory responses.
- Strong knowledge of cGMP, 21 CFR 210/211, OTC, validation requirements, and QMS systems.
- Exceptional communication and cross-functional collaboration skills.