Sr Manager, Clinical Quality

Reporting to the Director, R&D Quality, the Sr. Manager, R&D Quality is responsible for providing Quality Assurance oversight by executing audits, ensuring compliance with GCP, GLP, and/or GVP regulations, managing risk, supporting inspections, driving issue resolution, monitoring compliance metrics, updating procedures, and providing training.

This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.

• Quality Management System (QMS)
• Support the maintenance and continuous improvement of the Quality Management System
• Manage quality events including Deviations, CAPAs, Quality issues, Change controls, and Risk assessments
• Perform trend analysis and communicate quality metrics to senior leadership
• Ensure quality processes remain aligned with: ICH E6(R3), FDA regulations, global requirements, and GxP industry standards
• Inspection Readiness and Regulatory Support
• Participate in inspection readiness activities across clinical development functions
• Support development and review of regulatory responses, CAPA commitments, and root cause analyses
• Participate in the conduct of mock and actual inspections
• Audit Program Management
• Plan, conduct, and manage investigator site audits, CRO audits, vendor audits, system and process audits, pharmacovigilance audits (as applicable)
• Review audit reports and assess findings for risk and regulatory significance
• Monitor audit observations through completion and CAPA effectiveness verification
• Partner with business functions to assess and monitor outsourced activities
• Evaluate vendor quality systems and qualification packages
• Support vendor selection, qualification, and ongoing oversight
• Ensure vendor compliance with contractual and regulatory requirements
• Clinical Trial Quality Oversight
• Provide proactive quality oversight throughout the clinical trial lifecycle
• Support implementation of critical-to-quality factors and Risk-Based Quality Management (RBQM) strategies
• Collaborate with study teams to identify and mitigate compliance risks and ensure appropriate escalation pathways
• TMF and Data Integrity Oversight
• Partner with functional teams to ensure inspection-ready trial master files
• Support TMF quality reviews and remediation efforts
• Assess data integrity controls across clinical systems and processes
• Review quality events involving: eTMF systems, EDC systems, IRT platforms, safety databases, laboratory vendors
• SOP and Process Improvement
• Author, review, and revise quality and operational procedures
• Ensure procedures remain compliant and inspection-defensible
• Lead process improvement initiatives that enhance efficiency while maintaining compliance
• Training and Quality Culture
• Deliver quality training programs across R&D functions
• Mentor operational teams on inspection readiness and compliance expectations
• Promote a culture of quality, transparency, and continuous improvement
• Serve as a trusted advisor to functional leadership

• Requires a Bachelor's degree in Life Sciences or related discipline (Advanced degree a plus) with 8+ years of biotech/pharmaceutical experience
• Clear record of success in R&D QA in the biotech/pharmaceutical industry
• Thorough understanding of FDA, ICH and EMEA guidelines and regulations
• Excellent time management skills and the ability to work with a sense of urgency
• Demonstrated leadership and collaboration skills in a cross-functional project team
• Strong oral and written communication including the ability to present information clearly and logically
• Ability to anticipate and address issues, prioritize, and manage multiple projects to meet critical deadlines
• Strong attention to detail and problem-solving skills
• Works effectively in a team environment
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (Word, PowerPoint, Excel, Outlook, SharePoint, etc.)