Director/Senior Director, GMP Quality Assurance Operations in Waltham, Massachusetts at Crescent Biopharma

• 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.

• Bachelor’s degree in life sciences or a related discipline; advanced degree preferred.
• Director: 8-10 years of progressive experience in GMP Quality Assurance within biotech or pharmaceutical development.
• Senior Director: 10-12 years of progressive experience with demonstrated leadership in GMP QA Operations.
• Strong working knowledge of global GMP regulations and guidance (FDA, EMA, ICH) and phase-appropriate application for biologics spanning clinical-stage through late-stage development.
• Deep, hands-on experience supporting biologics manufacturing, including drug substance and drug product operations, from clinical through late-stage/commercial; experience with ADCs or complex modalities is a plus.
• Proven experience providing QA oversight of CDMOs, including selection, audits, investigations, change management, and issue resolution; experience leading tech transfers and supporting PPQ and BLA filings strongly preferred.
• 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 balance a high volume of ongoing clinical resupply and release activities with the strategic work of preparing a program for phase 3/commercial readiness.
• 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.
• Right attitude and aptitude for a small company environment—self-starting, comfortable with ambiguity and wearing multiple hats, and driven to get things done with both high quality and speed.
• Willingness and ability to travel to CDMO and other supplier sites for PIP, PPQ execution, and other on-site quality activities as needed.
• Commitment to fostering a culture of quality, integrity, inclusion, and continuous improvement.

Please note:

Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.

Please note, Crescent does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Crescent and the agency. Crescent will not pay any fees related to unsolicited resumes.

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