Director of Quality | Pharmaceutical Manufacturing | Relo Assistance

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 role is best suited for a hands-on Quality leader who enjoys being embedded in day-to-day manufacturing operations rather than operating solely at a strategic or enterprise level. The ideal candidate has spent the majority of their career directly supporting manufacturing floor operations, QA/QC teams, batch review, and production support within regulated pharmaceutical plants & experience working in small to mid-sized pharmaceutical manufacturing environments is strongly preferred.

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