Quality Director – 503B Pharmaceutical Manufacturing
A-Line Staffing Solutions LLC, Fort Worth, Texas, United States
NOW HIRING: Quality Director – 503B Pharmaceutical Manufacturing
Location:
Onsite – Dallas, TX Schedule:
Monday–Friday, Onsite Salary:
$150,000–$160,000 per year Relocation:
Candidates must already live in OR near Dallas, TX or be willing to relocate at their own expense (no relocation assistance) Benefits:
Full benefits package
Overview We are looking for an experienced
Quality Director
to lead the Quality function at a fast-growing
FDA-registered 503B Outsourcing Facility
. This is a
senior leadership role
for someone with deep experience in
sterile pharmaceutical manufacturing
who wants ownership over quality systems, compliance, and inspection readiness. You will be the go-to expert for
503B regulations, aseptic processing, and FDA compliance
, working closely with manufacturing and operations to ensure the highest quality standards are met. This is a hands-on, onsite leadership role in a high-growth environment.
JOB SUMMARY: Quality & Regulatory Leadership Serve as the primary quality and regulatory expert for sterile drug manufacturing Lead compliance with FDA 503B requirements, USP
, USP
, USP
, and cGMPs (21 CFR 210/211) Turn regulatory requirements into clear, practical quality systems Inspection & Audit Readiness Lead FDA inspections and external audits Ensure the facility is always inspection-ready Partner closely with Manufacturing, Engineering, Validation, and Operations teams Quality Systems & Operations Oversee batch record review, product release, and disposition Lead investigations, deviations, CAPAs, change controls, complaints, and recalls Ensure SOPs, validation documents, and environmental monitoring programs are current and compliant Validation & Continuous Improvement Review and approve validation plans for equipment, processes, utilities, and facilities Use quality metrics and data to drive continuous improvement Distribution Compliance Maintain compliance with wholesale drug distribution requirements Ensure documentation accuracy and traceability People Leadership Build, mentor, and lead a high-performing Quality team Promote a culture of accountability, compliance, and excellence
REQUIREMENTS: Bachelor’s degree in Engineering, Life Sciences, or related field 8+ years of experience in aseptic sterile drug manufacturing 5+ years of leadership experience in Quality or Compliance Strong working knowledge of: FDA 503B regulations; USP
, USP
, USP
; cGMP (21 CFR 210/211) Proven experience leading FDA inspections Master’s degree, PharmD, or MBA Experience in fast-growing pharmaceutical or compounding environments
Location:
Onsite – Dallas, TX Schedule:
Monday–Friday, Onsite Salary:
$150,000–$160,000 per year Relocation:
Candidates must already live in OR near Dallas, TX or be willing to relocate at their own expense (no relocation assistance) Benefits:
Full benefits package
Overview We are looking for an experienced
Quality Director
to lead the Quality function at a fast-growing
FDA-registered 503B Outsourcing Facility
. This is a
senior leadership role
for someone with deep experience in
sterile pharmaceutical manufacturing
who wants ownership over quality systems, compliance, and inspection readiness. You will be the go-to expert for
503B regulations, aseptic processing, and FDA compliance
, working closely with manufacturing and operations to ensure the highest quality standards are met. This is a hands-on, onsite leadership role in a high-growth environment.
JOB SUMMARY: Quality & Regulatory Leadership Serve as the primary quality and regulatory expert for sterile drug manufacturing Lead compliance with FDA 503B requirements, USP
, USP
, USP
, and cGMPs (21 CFR 210/211) Turn regulatory requirements into clear, practical quality systems Inspection & Audit Readiness Lead FDA inspections and external audits Ensure the facility is always inspection-ready Partner closely with Manufacturing, Engineering, Validation, and Operations teams Quality Systems & Operations Oversee batch record review, product release, and disposition Lead investigations, deviations, CAPAs, change controls, complaints, and recalls Ensure SOPs, validation documents, and environmental monitoring programs are current and compliant Validation & Continuous Improvement Review and approve validation plans for equipment, processes, utilities, and facilities Use quality metrics and data to drive continuous improvement Distribution Compliance Maintain compliance with wholesale drug distribution requirements Ensure documentation accuracy and traceability People Leadership Build, mentor, and lead a high-performing Quality team Promote a culture of accountability, compliance, and excellence
REQUIREMENTS: Bachelor’s degree in Engineering, Life Sciences, or related field 8+ years of experience in aseptic sterile drug manufacturing 5+ years of leadership experience in Quality or Compliance Strong working knowledge of: FDA 503B regulations; USP
, USP
, USP
; cGMP (21 CFR 210/211) Proven experience leading FDA inspections Master’s degree, PharmD, or MBA Experience in fast-growing pharmaceutical or compounding environments