Senior Director of Quality Assurance - GMP & Compliance

ADMA Biologics, Inc.; Boca Raton (FL); On-site; USD 170,000 - 210,000; Full time

Benefits offered by this job

401K plan with employer match and vest

Medical, Vision, Life and Dental

Pet Insurance

STD and LTD

Paid Holidays

3 Weeks' Paid Time Off

Tuition Assistance

Free shuttle to Boca Tri-Rail

Job summary

ADMA Biologics, Inc. in Boca Raton, FL seeks a Senior Director, Quality Assurance to lead the QA strategy across end-to-end production of specialty plasma-derived products. The role requires GMP expertise, strategic leadership, and the ability to resolve complex quality issues while ensuring reliable product supply.

You will manage QA teams, uphold cGMP systems, drive regulatory readiness, and collaborate with senior leadership to align quality objectives with business goals.

Qualifications

• Bachelor's degree in a scientific, engineering, or related field; advanced degree preferred.
• At least 15 years of progressive experience in pharmaceutical or biologics quality with GMP leadership.
• Thorough knowledge of FDA regulations and GMP for biological products.
• Experience leading investigations, risk assessments, change control, validation oversight, batch disposition, and inspections.
• Strong written communication, organizational, and people leadership skills.

Responsibilities

• Lead and develop QA teams for manufacturing oversight and quality systems execution.
• Provide leadership for cGMP quality systems: doc control, change control, investigations, deviations, CAPA, complaints.
• Provide independent QA oversight of plasma manufacturing operations, aseptic filling, packaging, and lab activities.
• Ensure effective communication of department goals across QA and with senior leaders.
• Oversee supplier and contract service quality, and drive continuous improvement.
• Participate in inspections and support FDA readiness.

Skills

Staff management

Cross-functional leadership

Communication skills

Education

Bachelor’s degree in science

Advanced degree preferred

Job description

ADMA Biologics, Inc. in Boca Raton, FL seeks a Senior Director, Quality Assurance to lead the QA strategy across end-to-end production of specialty plasma-derived products. The role requires GMP expertise, strategic leadership, and the ability to resolve complex quality issues while ensuring reliable product supply.

You will manage QA teams, uphold cGMP systems, drive regulatory readiness, and collaborate with senior leadership to align quality objectives with business goals.