Associate Director/Director, Analytical & GMP Quality Assurance Operations

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.

Responsibilities

• 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
  
  

Education & Experience

• 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
  
  

$0 - $0 a year

Additional Description For Pay Transparency

The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.