Director, GMP QA Operations – Biologics

OpenTalent; Waltham (MA); On-site; USD 180,000 - 230,000; Full time

Job summary

Crescent Biopharma is seeking a Director/Senior Director, GMP Quality Assurance Operations to lead strategic and hands-on QA for manufacturing activities supporting a lead biologics program. You will partner with cross-functional teams to ensure reliable clinical supply and to build a QA infrastructure for late-stage development and commercialization.

You will provide QA oversight across master cell bank, cell banks, drug substance, product, and finished goods within a global outsourced network,

Qualifications

• Experience leading GMP QA activities for biologics development.
• Proven track record with clinical supply and late-stage programs.
• Experience with tech transfer, process validation, and PPQ.
• Experience selecting and managing CDMOs and Quality Agreements.

Responsibilities

• Lead GMP QA activities for development programs, including master cell bank and drug product quality oversight.
• Own batch record review, disposition, and release for clinical resupply batches.
• Lead QA input into CDMO selection, onboarding and ongoing management.
• Oversee tech transfer, scale-up, process validation/qualification, and analytical method transfer.

Skills

GMP QA

Biologics

QA leadership

Regulatory audits

CDMO management

Job description

Crescent Biopharma is seeking a Director/Senior Director, GMP Quality Assurance Operations to lead strategic and hands-on QA for manufacturing activities supporting a lead biologics program. You will partner with cross-functional teams to ensure reliable clinical supply and to build a QA infrastructure for late-stage development and commercialization.

You will provide QA oversight across master cell bank, cell banks, drug substance, product, and finished goods within a global outsourced network,