Director of Quality | Pharmaceutical Manufacturing | Relo Assistance
The International Society for Pharmaceutical Engineering, Inc., Gulfport, 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
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
#J-18808-Ljbffr
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
#J-18808-Ljbffr