Director of Quality | Pharmaceutical Manufacturing | Relo Assistance
Phoenix VX, Gulfport, MS, United States
A well-established, FDA-regulated pharmaceutical manufacturing organization is seeking a Director of Quality to lead all Quality Assurance and Quality Control operations at its U.S. production site. This is a high-impact leadership opportunity to own and govern the full cGMP Quality Management System across both liquid and solid dose manufacturing in a commercial environment.
This role is ideal for a seasoned pharmaceutical quality leader who wants true authority, autonomy, and executive partnership within a stable, vertically integrated manufacturing organization.
The Opportunity
You will serve as the final authority for batch record review and product release , overseeing the integrity of the entire quality system in compliance with 21 CFR 210/211 . Reporting directly to executive leadership, you will ensure inspection readiness, sustained compliance, and operational excellence across QA and QC.
This is a hands-on leadership role where your decisions directly protect product quality, patient safety, and regulatory standing.
What You Will Own
- Design, implement, and maintain a fully compliant cGMP Quality Management System
- Final decision authority on batch record review and commercial product release
- Oversight of deviations, investigations, CAPAs, change control, and complaint handling
- Regulatory inspection leadership (PAI, routine, and for-cause)
- Governance of third-party contractors and laboratories
- Establishment and audit of procedures, specifications, and manufacturing controls
- Executive-level risk reporting and quality performance metrics
You will lead a team of approximately 25–30 quality professionals (QA and QC), including multiple managers and laboratory staff.
What We’re Looking For
- 10+ years of pharmaceutical manufacturing quality leadership experience
- Direct experience in commercial pharmaceutical production (not medical device or food)
- Deep expertise in 21 CFR 210/211 and FDA regulatory expectations
- Proven authority over final batch release decisions
- Experience leading FDA inspections and responding to regulatory observations
- Demonstrated oversight of deviations, CAPAs, investigations, and complaint systems
- Strong cross-functional leadership skills and executive communication ability
- Bachelor’s degree in Chemistry, Biology, or related discipline
This role requires someone who can operate independently, maintain regulatory integrity, and collaborate effectively with operations and scientific leadership.
About the Organization
- FDA-regulated manufacturing site operating since 1946
- Vertically integrated producer of liquid and solid dose medications
- One of the largest producers of liquid antacid products in the U.S.
- Approximately 100 employees
- 132,000-square-foot manufacturing facility
- Long-term ownership and stable operational history
The plant is located in Gulfport, Mississippi , approximately:
- 5 miles from the beach
- 1 hour from Mobile
- 1.5 hours from New Orleans
- Low cost of living with strong military and industrial presence in the region
- Base salary $120,000 – $150,000+ (flexible for the right candidate)
- Approximately 22 additional annual paid holiday closures
- Medical, Dental, Vision, Disability, and supplemental plans available