Director of Quality
Location: San Antonio, Texas
Relocation Assistance: Available
Visa Sponsorship: H-1B Transfer Sponsorship Available for Qualified Candidates
Reports To: Chief Executive Officer
Industry: Pharmaceutical Manufacturing / FDA Registered 503B Outsourcing Facility
Position Summary
We are seeking an experienced and highly motivated Director of Quality Assurance to lead and manage the Quality Assurance function at our FDA-registered 503B Outsourcing Facility. This individual will oversee all aspects of the Quality Management System (QMS), lead a team of Quality Assurance professionals, ensure compliance with current Good Manufacturing Practices (cGMP), and serve as a key leader during FDA inspections and regulatory audit including 483.
The ideal candidate will possess extensive experience in sterile pharmaceutical manufacturing, quality systems management, FDA inspections, CAPA, change control, deviation investigations, batch record review, and continuous quality improvement initiatives.
Key Responsibilities:
Quality Leadership
- Lead, mentor, and develop a team of 3–5 Quality Assurance professionals.
- Establish a culture of quality, compliance, accountability, and continuous improvement.
- Serve as a member of the site's leadership team.
Quality Management System (QMS)
- Develop, implement, and maintain robust Quality Systems in compliance with FDA cGMP requirements.
- Own and manage:
- SOP creation and revisions
- Change Control Program
- CAPA Program
- Deviation and Investigation Program
- Complaint Handling
- Risk Management
- Internal Audits
- Supplier Qualification Program
- Annual Product Reviews
FDA & Regulatory Compliance
- Lead FDA inspection readiness efforts.
- Act as primary QA representative during FDA inspections, customer audits, and regulatory interactions.
- Prepare and coordinate responses to FDA Form 483 observations and Warning Letters if required.
- Maintain compliance with:
- 21 CFR Parts 210 & 211
- 503B Outsourcing Facility requirements
- USP <797>, <800>, and applicable guidance
- Data Integrity requirements
- Sterility Assurance principles
Manufacturing Quality Oversight
- Review and approve:
- Batch Production Records
- Master Batch Records
- Validation Protocols and Reports
- Environmental Monitoring Reports
- Product Release Documentation
- Ensure quality oversight of sterile manufacturing operations.
- Partner with Operations, Microbiology, and QC Laboratory teams to resolve quality issues.
Validation & Qualification
- Oversee:
- Process Validation
- Media Fills
- Cleaning Validation
- Equipment Qualification (IQ/OQ/PQ)
- Computer System Validation
- Stability Programs
Continuous Improvement
- Analyze quality metrics and trends.
- Drive improvements in manufacturing quality, compliance, and operational efficiency.
- Lead root cause investigations and effectiveness checks.
QualificationsRequired
- Bachelor's degree in Pharmacy, Chemistry, Biology, Microbiology, Engineering, or related scientific field.
- Minimum 10 years of pharmaceutical quality experience.
- Minimum 5 years of leadership experience managing QA teams.
- Strong experience in sterile pharmaceutical manufacturing.
- Extensive knowledge of:
- FDA cGMP regulations (21 CFR Parts 210 & 211)
- 503B Outsourcing Facilities
- Quality Systems and Risk Management
- CAPA and Change Control Programs
- Batch Record Review and Product Release
- Demonstrated success during FDA inspections and regulatory audits.
Preferred
- Experience in an FDA-registered 503B Outsourcing Facility.
- Experience responding to FDA Form 483 observations.
- Analytical Lab expereince including HPLC
- Experience supporting Warning Letter remediation programs.
- ASQ Certified Quality Auditor (CQA) or Certified Quality Manager (CQM).
- Advanced degree (MS, PharmD, MBA, or PhD).
Desired Skills
- Strong leadership and people management skills.
- Excellent technical writing and SOP development abilities.
- Exceptional investigation and root cause analysis skills.
- Strong project management capabilities.
- Ability to influence cross-functional teams.
- Excellent verbal and written communication skills.
Compensation & Benefits
- Highly competitive salary based on experience.
- Annual performance bonus.
- Relocation assistance available.
- H-1B transfer sponsorship available for exceptional candidates.
- Medical, dental, and vision benefits.
- Paid time off and company holidays.
- Professional development opportunities.
Why Join Us?
- Join a rapidly growing FDA-registered 503B outsourcing facility.
- Lead quality department that directly impact patient safety.
- Work alongside experienced pharmaceutical manufacturing professionals.
- Opportunity to build and strengthen a world-class Quality Management System.
- Significant career growth and leadership opportunities.
Pay: $100,000.00 - $150,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Relocation assistance
Application Question(s):
- Do you have 5 years of working in the Pharmaceutical company as a Quality Director?
Experience:
- working at 503b facility?: 3 years (Required)
- working with FDA and dealing with 483: 3 years (Required)
Work Location: In person
