US Quality Assurance Director - GMP & Compliance

Doist; Pennington (NJ); On-site; USD 190,000 - 250,000; Full time

Benefits offered by this job

401(k) with company match

Paid parental leave

Flexible spending accounts

Job summary

GenScript USA Inc/ProBio Inc. is seeking a Head of Quality Assurance to lead the US QA organization and ensure compliance with FDA, EMA, ICH, and GMP regulations. You will drive QMS improvements, oversight of GMP manufacturing, and support cross-functional CDMO projects.

The role requires 10+ years in biotech/pharma QA leadership, strong leadership and stakeholder management, and proven experience with regulatory inspections and audits.

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Chemistry, or related field.
• Advanced degree (M.S. or Ph.D.) preferred.
• 10+ years of progressive Quality leadership experience in biotech/pharma/CDMO.

Responsibilities

• Lead US QA organization and ensure compliance with FDA, EMA, ICH, and GMP regulations.
• Develop and improve QMS including deviations, CAPA, change control, document control, risk management, training.
• Provide QA oversight for GMP manufacturing, tech transfer, validation, and batch release activities.
• Maintain inspection readiness for FDA, customers, and regulatory inspections/audits.
• Lead customer quality activities including Quality Agreements and audits.
• Collaborate with Manufacturing, Process Development, Engineering, Validation, Supply Chain, PM, and Commercial teams for CDMO projects.
• Drive continuous improvement to strengthen quality systems and organizational effectiveness.
• Coach and develop a high-performing QA team with a culture of quality.

Skills

Leadership

Regulatory compliance

Quality management

GMP knowledge

FDA inspections

Cross-functional collaboration

Strategic thinking

Education

Bachelor's in Life Sciences

MS/PhD preferred

Tools

QMS software

Document control systems

Job description

GenScript USA Inc/ProBio Inc. is seeking a Head of Quality Assurance to lead the US QA organization and ensure compliance with FDA, EMA, ICH, and GMP regulations. You will drive QMS improvements, oversight of GMP manufacturing, and support cross-functional CDMO projects.

The role requires 10+ years in biotech/pharma QA leadership, strong leadership and stakeholder management, and proven experience with regulatory inspections and audits.