Director, GMP QA Operations — Biologics & Tech Transfer

Socket.dev; Waltham (MA); On-site; USD 200,000 - 260,000; Full time

Benefits offered by this job

Base salary and bonus

Equity

100% employer-paid benefits

Flexible PTO

Professional development

Job summary

Crescent Biopharma is seeking a Director/Senior Director of GMP Quality Assurance Operations to provide strategic and hands-on leadership for manufacturing activities supporting its lead biologics program.

You will oversee quality across master cell bank, working cell bank, drug substance, drug product, and finished goods within a global outsourced network, ensuring quality systems and regulatory readiness for late-stage development and commercialization.

Qualifications

• Bachelor's degree in life sciences or related discipline; advanced degree preferred.
• Director: 8–10 years GMP QA in biotech/pharma; Senior Director: 10–12 years with leadership.
• Strong knowledge of FDA/EMA/ICH guidelines for biologics spanning clinical to late-stage development.
• Experience overseeing QA for biologics manufacturing (drug substance/product) and ADCs or complex modalities is a plus.
• Proven QA oversight of CDMOs including audits, investigations, and change management; PPQ and BLA support.
• Experience with regulatory submissions and responses to health authority questions; batch release and validation know-how.

Responsibilities

• Lead GMP QA activities for development programs across master cell bank to finished goods.
• Own batch records review, disposition, and release for clinical resupply batches.
• Lead QA input into CDMO selection, audits, and ongoing management; ensure late-stage/commercial readiness.
• Oversee tech transfer, scale-up, validation/qualification (facilities, utilities, equipment, PPQ, cleaning).
• Manage deviations, investigations, CAPAs, change control, and stability programs.
• Collaborate with CMC, Regulatory, Analytical Sciences, and Supply Chain to embed quality into programs.

Skills

GMP QA leadership

Biologics

CDMO oversight

Regulatory submissions

Process validation

Quality systems

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

eQMS

Job description

Crescent Biopharma is seeking a Director/Senior Director of GMP Quality Assurance Operations to provide strategic and hands-on leadership for manufacturing activities supporting its lead biologics program.

You will oversee quality across master cell bank, working cell bank, drug substance, drug product, and finished goods within a global outsourced network, ensuring quality systems and regulatory readiness for late-stage development and commercialization.