Associate Director/Director, Analytical & GMP Quality Assurance Operations

WalthamFull-timeexecutive

OtherQA & TestingQuality AssuranceQuality Assurance Lead

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Overview

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s pipeline includes its lead program,

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OtherQA & TestingQuality AssuranceQuality Assurance Lead

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s 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 therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visitwww.crescentbiopharma.comand follow the Company onLinkedInandX.

We are seeking an Associate Director or Director, Analytical & Operational Quality Assurance who will be responsible for providing strategic and hands-on QA oversight of analytical development, QC operations, and GMP operational quality activities across Crescent’s clinical-stage biologics and ADC programs. You will partner closely with CMC, Analytical Sciences, Quality Control, Technical Operations, and external manufacturing and testing partners to ensure phase-appropriate GMP compliance, robust data integrity, and inspection readiness within a highly outsourced operating model. In this role, you will play a critical role in shaping Crescent’s analytical quality strategy while ensuring disciplined execution of core quality systems that support aggressive development timelines.

Lead and execute QA oversight for analytical development and QC activities for assigned development programs and provide QA oversight across GMP manufacturing of master cell bank, working cell bank, drug substance, and drug product/finished goods, in alignment with Crescent’s Quality System

Serve as the primary QA interface to Analytical Sciences and Quality Control teams, ensuring quality is embedded in analytical strategies and execution

Provide QA oversight of analytical method development, qualification, validation, transfer, and lifecycle management

Lead QA oversight of OOS/OOT/OOE investigations, analytical deviations, and data integrity events

Oversee QA aspects of stability programs, reference standards, analytical trending, and method performance monitoring

Provide QA oversight of GMP operational activities, including manufacturing, testing, batch record review, disposition, and release of clinical materials

Support QA governance for tech transfer, scale-up, and validation/qualification activities (PPQ, cleaning, facilities, utilities, equipment)

Provide QA oversight of external QC laboratories, CDMOs, and key suppliers, including qualification, audits, Quality Agreements, and issue management

Execute and support core GMP quality systems, including deviations, investigations, CAPAs, change control, CPV, and batch review

Partner with Regulatory and CMC teams to support analytical and CMC sections of INDs, IMPDs, BLAs, and MAAs, and respond to health authority inquiries

Support regulatory inspections, partner audits, and ensure inspection readiness across analytical and operational areas

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 analytical and operational quality risks; propose mitigation strategies in partnership with Quality Management

Support GDP-related interfaces for assigned programs, including labeling/packaging operations, temperature excursions, complaints, returns, and QP Declaration, Certification, and release coordination

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

B.S. in life sciences or a related discipline; advanced degree preferred;10–12+ years of progressive experience with demonstrated leadership in GMP Quality Assurance within biotech or pharmaceutical development, with significant analytical and QC oversight experience

Strong working knowledge of global GMP regulations and guidance (FDA, EMA, ICH) and phase-appropriate application for clinical-stage biologics

Hands-on experience supporting biologics manufacturing, including drug substance and drug product operations; experience with ADCs or complex modalities is a plus

Proven experience providing QA oversight of CDMOs and external QC laboratories, including audits, investigations, change management, and issue resolution

Experience supporting regulatory submissions and inspections, including preparation of analytical and CMC-related documentation and health authority interactions

Solid understanding of validation principles, batch release processes, and analytical and stability programs

Demonstrated ability to operate effectively in a highly outsourced, fast-paced environment with evolving priorities

Strong collaboration, communication, and influencing skills, with the ability to balance compliance rigor and development agility

Hands-on, solutions-oriented mindset with the judgment to escalate issues appropriately and propose pragmatic, risk-based solutions

Commitment to fostering a culture of quality, integrity, inclusion, and continuous improvement