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ADMA Biologics, Inc. · 3 months ago

Associate Director, Quality Engineering

Boca Raton, FL

Full-time

Onsite

Lead/Staff, Director/Executive

10+ years exp

ADMA Biologics is a biopharmaceutical company dedicated to creating superior products for immunodeficient patients. They are seeking an Associate Director, Quality Engineering to provide leadership and oversight of Quality Engineering functions in support of GMP manufacturing operations, ensuring compliance with FDA regulations and company policies.

BiotechnologyHealth CareManufacturingMedical

No H1B

Responsibilities

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

Qualification

Quality EngineeringGMP manufacturingValidation lifecycleFDA regulationsComputerized systems validationData integrity principlesLeadership experienceAttention to detailTeam managementCross-functional collaboration

Required

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

Ability to follow the cGMP's and procedures with great attention to detail

Demonstrated ability to use computer software including MicroSoft Outlook, Word and Excel

FDA Adherence

Benefits

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-RailFree shuttle to the Boca Tri-Rail station

Company

ADMA Biologics, Inc.

ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases.

Founded in 2004

Ramsey, New Jersey, USA

501-1000 employees