What are the responsibilities and job description for the Associate Director, Quality Engineering position at Blue Coral Staffing Corp.?
Associate Director, Quality Engineering (Biotech / Pharmaceutical)
- Location: Boca Raton, FL
- 100% In-office, full time position
- 10 years of experience in Quality, Validation, or Engineering roles in Biotech or Pharmaceutical GMP manufacturing REQUIRED
- Compensation: $180,000 to $200,000 base salary range (commensurate with experience); discretionary bonus potential; competitive benefits package
- Relocation assistance available
Summary – Associate Director, Quality Engineering:
The Associate Director, Quality Engineering is responsible for providing leadership and oversight of Quality Engineering functions supporting Biotech / Pharmaceutical GMP (Good Manufacturing Practice) operations. Ensures facilities, utilities, equipment, and processes are qualified and validated in compliance with FDA regulations and company policies. Collaborate cross-functionally with Manufacturing, Facilities, Engineering, Validation, and Quality Assurance teams to maintain a state of control, enable continuous improvement, and ensure readiness for regulatory inspections.
- Lead and manage the Quality Engineering team supporting GMP facility & manufacturing operations
- Serve as subject matter expert for validation, equipment qualification, critical utilities, and process validation
- Set strategy and priorities for Quality Engineering activities to support current operations and new product introductions
- Oversee quality review/approval of validation protocols, reports, and change controls
- Support technology transfers, scale-up, and process validation activities in alignment with lifecycle approaches
- Drive risk-based decision-making and ensure effective quality risk management practices are in place
Qualifications – Associate Director, Quality Engineering:
- Bachelor’s degree in Engineering, Life Sciences, or related field REQUIRED (advanced degree preferred)
- 10 years of experience in Quality, Validation, or Engineering roles in Biotech or Pharmaceutical GMP manufacturing REQUIRED
- Strong knowledge of FDA and ICH guidance
- Deep expertise in validation lifecycle, equipment/facility qualification, utilities, and process validation
- Experience supporting regulatory inspections with strong knowledge of current industry expectations
- Familiarity with computerized systems validation and data integrity principles
- Demonstrated leadership and team management / supervision experience
- Ability to follow the cGMP’s & procedures with great attention to detail
- Proficiency with Microsoft Outlook / Word / Excel
Salary : $180,000 - $200,000
