Associate Director, Quality Engineering

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