Associate Director/Director, 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/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 operations
  
  

Education & 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
• 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.