Senior Director Quality Assurance

Job Title: Senior Director, Quality (GCP & NDA Focus)Location: Boston, MA (3 days onsite / 2 days remote)Position OverviewWe are seeking an experienced and strategic Senior Director of Quality to lead and oversee GCP quality systems and support NDA readiness and submissions. This role will be responsible for ensuring clinical quality compliance, inspection readiness, and alignment with global regulatory expectations across all GCP activities. The ideal candidate brings deep pharmaceutical/biotech experience and a strong track record of supporting successful regulatory filings, including NDAs.Key ResponsibilitiesGCP Quality LeadershipProvide strategic leadership for GCP Quality Assurance across clinical development programsOversee the development, implementation, and continuous improvement of GCP quality systems and processesEnsure compliance with global GCP regulations, ICH guidelines, and applicable health authority requirementsServe as the Quality lead for clinical trial activities, including vendor oversight and risk managementNDA Readiness & Regulatory SupportLead quality strategy and execution for NDA readiness, including gap assessments and remediation plansPartner cross-functionally with Regulatory Affairs, Clinical Development, and CMC to support submission activitiesEnsure inspection readiness for pre-approval inspections (PAIs) and health authority auditsProvide quality oversight of clinical data integrity and documentation supporting regulatory filingsAudit & Inspection ManagementOversee internal and external GCP audits, including CROs, clinical sites, and vendorsLead preparation and management of regulatory inspections (e.g., FDA, EMA)Ensure timely and effective CAPA development and implementationQuality Systems & ComplianceDrive continuous improvement of quality systems, including SOPs, training, and documentation practicesEnsure robust deviation, CAPA, and risk management processes are in placePromote a strong quality culture across the organizationLeadership & Cross-Functional CollaborationBuild and lead a high-performing Quality teamAct as a key advisor to senior leadership on GCP quality and regulatory riskCollaborate closely with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and CMC teamsQualificationsBachelor’s degree in Life Sciences or related field (advanced degree preferred)15+ years of experience in Quality within the pharmaceutical or biotechnology industrySignificant experience in GCP Quality Assurance and clinical trial oversightDemonstrated experience supporting NDA/BLA submissions and regulatory inspectionsStrong knowledge of global GCP regulations, ICH guidelines, and FDA/EMA expectationsProven leadership experience with the ability to influence cross-functional stakeholdersExperience managing audits, inspections, and CAPA processesExcellent communication, strategic thinking, and problem-solving skillsPreferred QualificationsExperience in both early and late-stage clinical developmentPrior experience interacting directly with regulatory agenciesBackground in building or scaling quality systems in a growing organizationWork EnvironmentHybrid role based in Boston, MA3 days onsite required with flexibility for remote work the remainder of the weekWhy Join UsOpportunity to play a critical role in advancing innovative therapiesHigh-impact position with visibility to executive leadershipCollaborative and mission-driven culture