Strategic GMP QA Operations Director

Crescent Biopharma; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

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

You will oversee master cell bank, drug substance, and drug product quality, drive tech transfer and process validation, and ensure compliance with Part 11/Annex 11 within a global outsourced network.

Qualifications

• Director-level GMP QA leadership for development programs and clinical supply.
• Experience with master cell bank, working cell bank, drug substance, and drug product quality.
• Strong involvement in CDMO selection, audits, and regulatory interactions.

Responsibilities

• Lead GMP QA activities across development programs and clinical studies.
• Own batch review, disposition, and release within delegated authority; support QP/RP interactions.
• Drive tech transfer, process validation/qualification, and PPQ for late-stage programs.
• Maintain eQMS, ensure data integrity, and support regulatory submissions.

Skills

GMP QA

Quality Systems

CMC Collaboration

Regulatory Compliance

Audits

Process Validation

Tech Transfer

Risk Management

Leadership

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

eQMS

DMS

LMS

Job description

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

You will oversee master cell bank, drug substance, and drug product quality, drive tech transfer and process validation, and ensure compliance with Part 11/Annex 11 within a global outsourced network.