Sr Manager, Clinical Quality

Sr Manager – Clinical GCP QualityFull-Time, Permanent Waltham, MA (Hybrid)Summary: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.ResponsibilitiesQuality Management System (QMS)Support the maintenance and continuous improvement of the Quality Management SystemManage quality events including Deviations, CAPAs, Quality issues, Change controls, and Risk assessmentsPerform trend analysis and communicate quality metrics to senior leadershipEnsure quality processes remain aligned with: ICH E6(R3), FDA regulations, global requirements, and GxP industry standardsInspection Readiness and Regulatory SupportParticipate in inspection readiness activities across clinical development functionsSupport development and review of regulatory responses, CAPA commitments, and root cause analysesParticipate in the conduct of mock and actual inspectionsAudit Program ManagementPlan, 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 significanceMonitor audit observations through completion and CAPA effectiveness verificationVendor OversightPartner with business functions to assess and monitor outsourced activitiesEvaluate vendor quality systems and qualification packagesSupport vendor selection, qualification, and ongoing oversightEnsure vendor compliance with contractual and regulatory requirementsClinical Trial Quality OversightProvide proactive quality oversight throughout the clinical trial lifecycleSupport implementation of critical-to-quality factors and Risk-Based Quality Management (RBQM) strategiesCollaborate with study teams to identify and mitigate compliance risks and ensure appropriate escalation pathwaysTMF and Data Integrity OversightPartner with functional teams to ensure inspection-ready trial master filesSupport TMF quality reviews and remediation effortsAssess data integrity controls across clinical systems and processesReview quality events involving: eTMF systems, EDC systems, IRT platforms, safety databases, laboratory vendorsSOP and Process ImprovementAuthor, review, and revise quality and operational proceduresEnsure procedures remain compliant and inspection-defensibleLead process improvement initiatives that enhance efficiency while maintaining complianceTraining and Quality CultureDeliver quality training programs across R&D functionsMentor operational teams on inspection readiness and compliance expectationsPromote a culture of quality, transparency, and continuous improvementServe as a trusted advisor to functional leadershipQualifications:Requires a Bachelor's degree in Life Sciences or related discipline (Advanced degree a plus) with 8+ years of biotech/pharmaceutical experienceClear record of success in R&D QA in the biotech/pharmaceutical industryThorough understanding of FDA, ICH and EMEA guidelines and regulationsExcellent time management skills and the ability to work with a sense of urgencyDemonstrated leadership and collaboration skills in a cross-functional project teamStrong oral and written communication including the ability to present information clearly and logicallyAbility to anticipate and address issues, prioritize, and manage multiple projects to meet critical deadlinesStrong attention to detail and problem-solving skillsWorks effectively in a team environmentStrong commitment to ethical standardsProficient with Microsoft Office suite (Word, PowerPoint, Excel, Outlook, SharePoint, etc.)