Quality Assurance Director | Pharmaceutical Manufacturing
Phoenix VX, Gulfport, MS, United States
A reputable FDA-regulated pharmaceutical manufacturing organization is looking for a
Quality Assurance Director
to lead and oversee all
Quality Assurance and Quality Control operations
at its U.S. production site. This is a significant leadership position where you will have the autonomy and authority to manage the full cGMP Quality Management System for both
liquid and solid dose manufacturing
in a commercial setting. This role is perfect for a seasoned quality leader in the pharmaceutical industry who desires a position with real executive authority and partnership within a stable and integrated manufacturing organization. The Opportunity As the
final authority for batch record review and product release , you will oversee the integrity of the quality system, ensuring compliance with
21 CFR 210/211 . You will report directly to the executive leadership team, ensuring inspection readiness, compliance, and operational excellence in QA and QC. Your leadership will directly impact product quality, patient safety, and regulatory compliance. What You Will Own Design and maintain a fully compliant
cGMP Quality Management System Decide on
batch record review and commercial product releases Oversee
deviations, investigations, CAPAs, change controls, and complaint handling Lead regulatory inspections (PAI, routine, and for-cause) Govern third-party contractors and laboratories Establish, maintain, and audit procedures, specifications, and manufacturing controls Report on risk and quality performance metrics at the executive level Leading a team of approximately
25-30 quality professionals
(QA and QC), including multiple managers and laboratory staff will be part of your responsibilities. What We're Looking For 10+ years of leadership experience in pharmaceutical manufacturing quality Direct experience in commercial pharmaceutical production
(not related to medical devices or food) Deep expertise in
21 CFR 210/211 and FDA regulatory expectations Proven authority over
final batch release decisions Experience with leading FDA inspections and addressing regulatory observations Demonstrated management skills over
deviations, CAPAs, investigations, and complaint systems Strong leadership skills and effective executive communication Bachelor's degree in Chemistry, Biology, or a related field The ideal candidate will operate independently, uphold regulatory integrity, and engage effectively with operations and scientific leadership. About the Organization FDA-regulated manufacturing site in operation since 1946 A prominent producer of liquid and solid dose medications One of the largest manufacturers of liquid antacid products in the U.S. About 100 employees 132,000 square feet of manufacturing space Stable operational history under long-term ownership The plant is located in
Gulfport, Mississippi , with the following highlights: 5 miles from the beach 1 hour from Mobile 1.5 hours from New Orleans Low cost of living with a robust military and industrial presence in the area Compensation & Benefits Base salary ranging from $120,000 - $150,000+ (flexible for the right candidate) Relocation assistance available PTO along with additional paid holidays Approximately 22 extra paid holiday closures annually Health, Dental, Vision, Disability, and supplemental plans available Interview Process Initial HR screening Executive virtual interviews Onsite interview Job offer
Quality Assurance Director
to lead and oversee all
Quality Assurance and Quality Control operations
at its U.S. production site. This is a significant leadership position where you will have the autonomy and authority to manage the full cGMP Quality Management System for both
liquid and solid dose manufacturing
in a commercial setting. This role is perfect for a seasoned quality leader in the pharmaceutical industry who desires a position with real executive authority and partnership within a stable and integrated manufacturing organization. The Opportunity As the
final authority for batch record review and product release , you will oversee the integrity of the quality system, ensuring compliance with
21 CFR 210/211 . You will report directly to the executive leadership team, ensuring inspection readiness, compliance, and operational excellence in QA and QC. Your leadership will directly impact product quality, patient safety, and regulatory compliance. What You Will Own Design and maintain a fully compliant
cGMP Quality Management System Decide on
batch record review and commercial product releases Oversee
deviations, investigations, CAPAs, change controls, and complaint handling Lead regulatory inspections (PAI, routine, and for-cause) Govern third-party contractors and laboratories Establish, maintain, and audit procedures, specifications, and manufacturing controls Report on risk and quality performance metrics at the executive level Leading a team of approximately
25-30 quality professionals
(QA and QC), including multiple managers and laboratory staff will be part of your responsibilities. What We're Looking For 10+ years of leadership experience in pharmaceutical manufacturing quality Direct experience in commercial pharmaceutical production
(not related to medical devices or food) Deep expertise in
21 CFR 210/211 and FDA regulatory expectations Proven authority over
final batch release decisions Experience with leading FDA inspections and addressing regulatory observations Demonstrated management skills over
deviations, CAPAs, investigations, and complaint systems Strong leadership skills and effective executive communication Bachelor's degree in Chemistry, Biology, or a related field The ideal candidate will operate independently, uphold regulatory integrity, and engage effectively with operations and scientific leadership. About the Organization FDA-regulated manufacturing site in operation since 1946 A prominent producer of liquid and solid dose medications One of the largest manufacturers of liquid antacid products in the U.S. About 100 employees 132,000 square feet of manufacturing space Stable operational history under long-term ownership The plant is located in
Gulfport, Mississippi , with the following highlights: 5 miles from the beach 1 hour from Mobile 1.5 hours from New Orleans Low cost of living with a robust military and industrial presence in the area Compensation & Benefits Base salary ranging from $120,000 - $150,000+ (flexible for the right candidate) Relocation assistance available PTO along with additional paid holidays Approximately 22 extra paid holiday closures annually Health, Dental, Vision, Disability, and supplemental plans available Interview Process Initial HR screening Executive virtual interviews Onsite interview Job offer