Director, GMP Quality Assurance for Biologics

Crescent Biopharma, Inc.; Waltham (MA); On-site; USD 170,000 - 230,000; Full time

Job summary

Crescent Biopharma, Inc. is seeking a Director/Senior Director, GMP Quality Assurance Operations to lead strategic and hands-on quality leadership for manufacturing activities supporting the lead biologics program and future pipeline growth.

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

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• Director level experience in GMP quality operations or equivalent role.
• Experience enabling clinical supply, tech transfer, and regulatory readiness.

Responsibilities

• Lead GMP Quality Assurance activities for development programs, overseeing master cell bank to drug product.
• Own batch record review, disposition, and release for clinical batches with delegated authority.
• Lead QA input into CDMO selection, onboarding, and ongoing management for programs.

Skills

GMP Quality Assurance

Quality System

Regulatory collaboration

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

eQMS

DMS

LMS

Job description

Crescent Biopharma, Inc. is seeking a Director/Senior Director, GMP Quality Assurance Operations to lead strategic and hands-on quality leadership for manufacturing activities supporting the lead biologics program and future pipeline growth.

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