Senior Director, R&D Quality Assurance (GCP-GLP-GvP) in Waltham, Massachusetts at Crescent Biopharma , Inc.

We are seeking a Senior Director, R&D Quality (GCP–GLP–GvP) is a key leader within Crescent’s Quality organization, responsible for providing strategic and hands-on Quality Assurance leadership for clinical, nonclinical, and pharmacovigilance activities across Crescent’s development programs. You partner closely with Clinical Development, Clinical Operations, Nonclinical Development, Pharmacovigilance, Regulatory, and external partners to ensure phase-appropriate compliance with global GxP regulations, robust data integrity, and continuous inspection readiness within a highly outsourced development model.

• Provide leadership and direction for QA activities supporting GCP, GLP, and GvP programs across all phases of development.
• Serve as the primary QA interface to Clinical Development, Clinical Operations, Nonclinical, and Pharmacovigilance teams.
• Ensure compliance with global regulatory requirements, including ICH E6 (R2/R3), FDA, EMA, and OECD GLP guidelines.
• Develop, implement, and maintain QA policies, SOPs, and training programs aligned with regulatory expectations and phase-appropriate needs.
• Lead QA oversight of CROs and R&D vendors across clinical, nonclinical, and pharmacovigilance activities, including governance, quality agreements, CAPA management, and ongoing performance oversight.
• Develop and execute a risk-based audit strategy for clinical and nonclinical studies, including CROs, clinical sites, laboratories, and vendors.
• Conduct and/or oversee internal and external audits; issue audit reports and ensure timely, effective CAPA development and closure.
• Lead the identification, investigation, and resolution of GCP/GLP/GvP quality issues through a robust deviation and CAPA management process.
• Ensure appropriate QA oversight of clinical data systems and platforms (e.g., EDC, eTMF, RTSM, safety databases), including validation, data integrity, and compliance with applicable GxP and Part 11 / Annex 11 requirements.
• Provide QA oversight of clinical and nonclinical documentation, including but not limited to protocols, study plans, reports, safety documentation, and regulatory submissions.
• Partner with cross-functional teams to support study execution, end-to-end data flow and data integrity, and inspection readiness.
• Support and lead (where applicable) regulatory authority inspections and partner audits, including inspection preparation, participation, and follow-up activities.
• Track and report R&D quality metrics and trends; drive continuous improvement initiatives across clinical, nonclinical, and safety operations.
• Support implementation and use of electronic quality systems (eQMS, DMS, LMS), ensuring compliance with Part 11 / Annex 11 and data integrity expectations for R&D records.
• Contribute to quality risk management activities by identifying, assessing, and escalating R&D quality risks; propose mitigation strategies in partnership with Quality Management.
• 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 global GCP, GLP, and GvP regulations, guidance, and industry best practices, and proactively apply learnings to Crescent’s R&D operations.

• Bachelor’s degree in life sciences or a related field; advanced degree preferred.
• 10+ years of progressive Quality Assurance experience within biotech or pharmaceutical development, with deep expertise across GCP, GLP, and GvP activities.
• In-depth knowledge of global regulations and guidance, including ICH E6 (R2/R3), FDA regulations, EU GCP/GLP requirements, and OECD principles.
• Advanced understanding of global regulatory requirements (U.S., EU, ICH) and phase-appropriate quality standards across R&D programs; oncology experience preferred.
• Strong expertise in quality systems, including deviations, CAPAs, root cause analysis, and quality risk management.Demonstrated experience supporting regulatory inspections and global submissions (e.g., INDs, NDAs, BLAs, MAAs), including responses to health authority queries (e.g., FDA, EMA).
• Proven ability to provide QA oversight in a highly outsourced development environment.
• Strategic, hands-on leader with the ability to balance long-term planning and day-to-day execution.
• Proven experience developing strong partnerships with cross-functional stakeholders to ensure strategic business goals are met through collaboration and knowledge sharing.
• Strong collaboration, communication, and influencing skills, with sound judgment and a risk-based decision-making approach.
• Ability to thrive in a fast-paced, evolving environment while managing competing priorities.
• 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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