Blue Coral Staffing Corp. ยท 1 month ago
Associate Director, Quality Engineering
Boca Raton, FL
Full-time
Onsite
Lead/Staff, Director/Executive
$180K/yr - $200K/yr
10+ years expBlue Coral Staffing Corp. is seeking an Associate Director, Quality Engineering to provide leadership and oversight of Quality Engineering functions in the Biotech and Pharmaceutical sectors. The role involves ensuring compliance with FDA regulations, managing the Quality Engineering team, and collaborating with cross-functional teams to maintain operational control and readiness for regulatory inspections.
Staffing & Recruiting
Hiring Manager
David Eitches
Responsibilities
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
Qualification
Required
10+ years of experience in Quality, Validation, or Engineering roles in Biotech or Pharmaceutical GMP manufacturing REQUIRED
Bachelor's degree in Engineering, Life Sciences, or related field 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
Preferred
advanced degree preferred
Benefits
Discretionary bonus potential
Competitive benefits package
Relocation assistance available
Company
Blue Coral Staffing Corp.
Direct-Hire placement of professionals along multiple verticals: Finance, Accounting, HR, Operations, IT, Legal, Admin/Executive Admin Support, Sales & Marketing and beyond...
2-10 employees
Funding
Current Stage
Early StageLeadership Team
David Eitches
Managing Partner
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