Director/Senior Director, GMP Quality Assurance Operations

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’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapiesas single agentsand as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.

We are seeking a Director/Senior Director, GMP Quality Assurance Operations. You will be responsible for providing strategic and hands-on GMP Quality leadership for manufacturing activities supporting the lead biologics program and future pipeline growth. Partnering closely with the GMP Quality and cross-functional Technical Operations teams, you will ensure reliable clinical supply while building the Quality infrastructure needed to successfully advance programs into late-stage development and commercialization.

You will provide Quality oversight across master cell bank, working cell bank, drug substance, drug product, and finished goods within a global outsourced manufacturing network. You will bring deep biologics experience spanning clinical through late-stage development, with demonstrated expertise supporting clinical supply, technology transfer, CDMO selection and management, process validation/PPQ, and commercial readiness, including BLA support.

Responsibilities

• Lead and execute GMP Quality Assurance activities for assigned development programs, including manufacture of master cell bank, working cell bank, drug substance, and drug product/finished goods, in alignment with Crescent’s Quality System, across a growing portfolio of clinical studies within a platform program.
• Own batch record review, disposition, and release activities for a high volume of clinical resupply batches, in accordance with delegated authority and established procedures; support QP/RP interactions and governance where applicable, ensuring quality operations keep pace with growing supply demand.
• Lead QA input into CDMO selection, onboarding, and ongoing management for assigned programs, including risk-based qualifications, audits, Quality Agreements, issue management, and performance monitoring, with an eye toward late-stage and commercial fit.
• Lead and manage QA activities related to tech transfer, scale-up, process validation/qualification (facilities, utilities, equipment, PPQ, cleaning), and analytical method validation and transfer, positioning the program for successful PPQ execution and BLA readiness.
• Execute and support core GMP quality systems, including deviations, investigations, CAPAs, change control, batch review, CPV, OOS/OOT/OOE management, and stability programs, ensuring timely and compliant closure.
• Partner closely with CMC, Technical Operations, Analytical Sciences, Quality Control, and Supply Chain, and Regulatory teams to embed quality oversight into program execution and manufacturing timelines.
• Provide QA input to CMC development and regulatory strategies, including phase -appropriate review and approval of applicable development deliverables and review and contribution to CMC sections of INDs, IMPDs, BLAs, and MAAs, and support responses to health authority inquiries.
• Support implementation and use of electronic quality systems (eQMS, DMS, LMS), ensuring compliance with Part 11 / Annex 11 and data integrity expectations for GMP records.
• Contribute to quality risk management activities by identifying, assessing, and escalating GMP-related risks; propose mitigation strategies in partnership with Quality Management.
• Support quality oversight of dose expansion cohorts, including combination regimens involving standard of care product, ensuring appropriate quality controls and documentation across the combined supply chain.
• Support GDP-related interfaces for assigned programs, including labeling/packaging operations, temperature excursions, complaints, deviations, returns, managing QP Declaration and Certification activities, QP release coordination, and traceability requirements as applicable.
• Track and report program-level GMP quality metrics and trends; support continuous improvement initiatives across manufacturing and supply operations.
• Mentor junior QA staff and external consultants as applicable, contributing to a strong quality culture grounded in collaboration, accountability, and continuous learning.
• Stay current on evolving GMP regulations, guidance, and industry best practices, and proactively apply learnings to Crescent’s operations.

Education & Experience

• Bachelor’s degree in life sciences or a related discipline; advanced degree preferred.
• Director