Blue Coral Staffing Corp.
Associate Director, Quality Engineering
Blue Coral Staffing Corp., Boca Raton, Florida, us, 33481
Pay Range
Blue Coral Staffing Corp. provided pay range: $180,000.00/yr - $200,000.00/yr.
Additional Compensation
Annual Bonus
Position Title Associate Director, Quality Engineering (Biotech / Pharmaceutical)
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
Seniority Level Mid-Senior level
Employment Type Full-time
Job Function Quality Assurance, Manufacturing, and Engineering
Industries Pharmaceutical Manufacturing, Biotechnology Research, and Manufacturing
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Additional Compensation
Annual Bonus
Position Title Associate Director, Quality Engineering (Biotech / Pharmaceutical)
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
Seniority Level Mid-Senior level
Employment Type Full-time
Job Function Quality Assurance, Manufacturing, and Engineering
Industries Pharmaceutical Manufacturing, Biotechnology Research, and Manufacturing
#J-18808-Ljbffr