Director of Quality
Silicon Valley Recruiting•Gulfport, MS
15h•Onsite
About The Position
The Director of Quality provides strategic and operational leadership for all Quality Assurance and Quality Control activities at an FDA-regulated pharmaceutical manufacturing site. The role oversees development, implementation, and maintenance of a compliant cGMP Quality Management System supporting commercial liquid and solid dose production. This position serves as the sites primary quality authority and regulatory representative.
Requirements
- Bachelors degree in Life Sciences or related field (advanced degree preferred)
- 10+ years pharmaceutical manufacturing quality experience
- Prior leadership responsibility over QA and QC teams
- Strong working knowledge of FDA regulations and cGMP requirements
- Experience in commercial manufacturing environments
- Demonstrated regulatory inspection leadership
Responsibilities
- Lead site Quality Assurance and Quality Control organizations
- Maintain Quality Management System compliant with 21 CFR 210/211
- Final approval authority for batch disposition and product release
- Manage: Deviations & investigations
- CAPA programs
- Change control
- Complaint handling
- Support regulatory inspections and audits as lead quality representative
- Ensure ongoing inspection readiness
- Partner with Manufacturing, Technical Operations, and Executive Leadership
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What This Job Offers
Job Type
Full-time
Career Level
Director
