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

Why Join Us

• High-impact leadership role with real ownership
• Opportunity to build and shape quality systems at scale
• Work with a mission-driven organization focused on improving healthcare access
• Long-term growth potential as the organization expands nationally

APPLY TODAY or Contact Recruiter:

Alliston Brown | 586-710-7944| alliston@alinestaffing.com