Director of Quality | Pharmaceutical Manufacturing | Relo Assistance
Phoenix VX, Horn Lake, 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
2530 quality professionals
(QA and QC), including multiple managers and laboratory staff. What Were 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 Bachelors 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
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
2530 quality professionals
(QA and QC), including multiple managers and laboratory staff. What Were 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 Bachelors 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