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 OpportunityYou 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 OwnDesign, implement, and maintain a fully compliant cGMP Quality Management SystemFinal decision authority on batch record review and commercial product releaseOversight of deviations, investigations, CAPAs, change control, and complaint handlingRegulatory inspection leadership (PAI, routine, and for-cause)Governance of third-party contractors and laboratoriesEstablishment and audit of procedures, specifications, and manufacturing controlsExecutive-level risk reporting and quality performance metricsYou will lead a team of approximately 25–30 quality professionals (QA and QC), including multiple managers and laboratory staff.What We're Looking For10+ years of pharmaceutical manufacturing quality leadership experienceDirect experience in commercial pharmaceutical production (not medical device or food)Deep expertise in 21 CFR 210/211 and FDA regulatory expectationsProven authority over final batch release decisionsExperience leading FDA inspections and responding to regulatory observationsDemonstrated oversight of deviations, CAPAs, investigations, and complaint systemsStrong cross-functional leadership skills and executive communication abilityBachelor's degree in Chemistry, Biology, or related disciplineThis role requires someone who can operate independently, maintain regulatory integrity, and collaborate effectively with operations and scientific leadership.About the OrganizationFDA-regulated manufacturing site operating since 1946Vertically integrated producer of liquid and solid dose medicationsOne of the largest producers of liquid antacid products in the U.S.Approximately 100 employees132,000-square-foot manufacturing facilityLong-term ownership and stable operational historyThe plant is located in Gulfport, Mississippi, approximately:5 miles from the beach1 hour from Mobile1.5 hours from New OrleansLow cost of living with strong military and industrial presence in the regionCompensation & BenefitsBase salary $120,000 – $150,000+ (flexible for the right candidate)Relocation support availablePTO plus additional paid holidaysApproximately 22 additional annual paid holiday closuresMedical, Dental, Vision, Disability, and supplemental plans availableInterview ProcessBrief HR screenExecutive virtual interviewOnsite interviewOffer