Associate Director/Director, 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/Director, GMP Quality Assurance Operations to be a key leader within Crescent’s Quality organization, responsible for providing hands-on Quality Operations oversight for GMP manufacturing activities supporting one or more of Crescent’s bispecific antibody and/or antibody-drug conjugate (ADC) programs. You will oversees quality activities across the manufacture of master cell bank, working cell bank, drug substance, and drug product/finished goods within a highly outsourced development and manufacturing model, and partners closely with the Senior Director of Quality and cross-functional teams to ensure phase-appropriate GMP compliance, effective execution of quality systems, and continuous inspection readiness while supporting aggressive development timelines.

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

Support batch record review, disposition, and release activities for clinical materials, in accordance with delegated authority and established procedures; support QP/RP interactions and governance where applicable

Provide hands-on QA oversight of CDMOs and key suppliers supporting assigned programs, including risk-based qualifications, audits, Quality Agreements, issue management, and performance monitoring

Serve as the primary QA point of contact for GMP activities related to tech transfer, scale-up, process validation/qualification (facilities, utilities, equipment, PPQ, cleaning), and analytical method validation and transfer

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 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

B.S. in life sciences or a related discipline; advanced degree preferred; a minimum of 8 years of progressive experience in GMP Quality Assurance within biotech or pharmaceutical development.

Demonstrated leadership in GMP QA Operations

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, including audits, investigations, change management, and issue resolution

Experience supporting regulatory submissions and inspections, including preparation of CMC-related documentation and responses to health authority questions

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

Demonstrated ability to operate effectively in a highly outsourced, fast-paced development 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