Associate Director, Quality Engineering

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart.

If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for an Associate Director, Quality Engineering in Boca Raton, FL!

Position Summary:

The Associate Director, Quality Engineering is responsible for providing leadership and oversight of Quality Engineering functions supporting GMP manufacturing operations. This role ensures that facilities, utilities, equipment, and processes are qualified and validated in compliance with FDA regulations and company policies.

The Associate Director will 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 and manufacturing operations.
• Serve as SME 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.
• Ensure validation and qualification programs (facilities, utilities, equipment, cleaning, process, and computerized systems) meet regulatory expectations and company standards.
• Oversee quality review/approval of validation protocols, reports, and change controls.
• Partner with Quality Systems to manage deviations, investigations, CAPAs, and change controls related to engineering and validation activities.
• Provide guidance during regulatory inspections.
• Collaborate with Facilities/Engineering on maintenance and calibration programs for GMP-critical equipment and systems.
• Support technology transfers, scale-up, and process validation activities in alignment with lifecycle approaches (e.g., CPV, Stage 1–3 validation).
• Drive risk-based decision-making and ensure effective quality risk management practices are in place.
• Champion continuous improvement initiatives to optimize compliance, efficiency, and reliability.

• Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred.
• 10+ years of experience in Quality, Validation, or Engineering roles in biotech or pharmaceutical GMP manufacturing.
• Strong knowledge of FDA and ICH guidance (e.g., ICH Q8–Q10).
• 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 (21 CFR Part 11).
• Demonstrated leadership and team management experience.

Compliance Requirements (ES):
The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities.

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company Paid Holidays
• 3 Weeks’ Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail
• Free shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit (Use the "Apply for this Job" box below). ADMA Biologics is an Equal Opportunity Employer.