Director/Senior Director, GMP Quality Assurance Operations

About the role

Crescent Biopharma is seeking a Director/Senior Director, GMP Quality Assurance Operations to lead and execute GMP Quality Assurance activities for assigned development programs. This role requires deep biologics experience spanning clinical through late-stage development, with a focus on manufacturing activities supporting the lead biologics program and future pipeline growth.

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 MAA's, 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.

Requirements

• 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.

Qualifications

• Hands-on experience supporting biologics manufacturing, including drug substance and drug product operations, from clinical through late-stage/commercial.
• Experience with CDMO selection, onboarding, and ongoing management.
• Experience leading tech transfers and supporting process validation/qualification.
• Experience with analytical method validation and transfer.
• Experience with batch release processes and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions and inspections.
• Experience with electronic quality systems (eQMS, DMS, LMS).
• Experience with GMP regulations and guidance (FDA, EMA, ICH).
• Experience with validation principles, batch release processes, and analytical and stability programs.
• Experience with regulatory submissions