Job Details

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

Compensation & Benefits

• Base salary $120,000 – $150,000+ (flexible for the right candidate)
• Relocation support available
• PTO plus additional paid holidays
• Approximately 22 additional annual paid holiday closures
• Medical, Dental, Vision, Disability, and supplemental plans available

Interview Process

• Brief HR screen
• Executive virtual interview
• Onsite interview
• Offer