Associate Director/Director, GMP Quality Assurance Operations
28 days ago
Waltham
Job DescriptionCrescent 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, visit 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.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, • 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 operationsEducation & Experience, • 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