Director Clinical Quality Assurance

Director, Clinical Quality AssuranceBoston, MAA clinical-stage biopharmaceutical company focused on developing innovative medicines for patients with significant unmet medical needs is seeking an experienced Director, Clinical Quality Assurance to manage clinical quality activities supporting its development programs and ensure compliance with applicable regulatory requirements and company policies.This role reports to the VP of Quality and will lead GCP compliance and quality oversight across clinical programs. The Director will develop and implement risk-based quality strategies, manage audits and inspection readiness, oversee service providers, and ensure global regulatory compliance. The role will partner cross-functionally to drive continuous improvement, strengthen sponsor oversight, and proactively identify and mitigate quality risks.The ideal candidate will thrive in a collaborative, entrepreneurial environment and bring strong technical expertise, sound judgment, and a continuous-improvement mindset. This position is based in Boston, with a strong preference for being onsite 4 days per week.Key ResponsibilitiesInform and contribute to clinical audit planning and strategyPerform and/or coordinate clinical site and vendor auditsOversee deviations, quality issues, CAPAs, effectiveness checks, root cause analyses, and related KPIsAdvise internal stakeholders and external partners on GCP compliance and identify emerging compliance trendsSupport inspection readiness activities and regulatory inspectionsDevelop and deliver GCP-related training and contribute to the development, revision, and maintenance of policies, SOPs, and work instructionsConduct and/or manage qualification and ongoing oversight of service providersEnsure service providers adhere to quality programs and applicable regulatory requirementsAssess and escalate compliance risks related to subject safety, data integrity, and business continuityLead or support preparation for and responses to regulatory audits and inspections, including timely remediation of findingsSupport IND submissions and related correspondence with global regulatory authoritiesIdentify opportunities for process improvement and drive continuous improvement across clinical quality activitiesPerform other duties as assignedQualificationsBachelor's degree with 12+ years of relevant experience, preferably within the life sciences, including 8+ years in Clinical Quality Assurance, or an equivalent combination of relevant QA/PV experienceStrong knowledge of global regulations and guidelines, including FDA, EMA, ICH, GxP, and applicable safety reporting requirementsBroad clinical development experience across Phase I through NDA/BLAStrong understanding of GCP quality principles across clinical developmentProven experience developing and implementing risk-based Clinical Quality Assurance programsDemonstrated success leading clinical site and vendor audits, supporting regulatory inspections, and managing responses to findingsStrong ability to communicate quality events, risks, and outcomes to internal stakeholdersExcellent interpersonal, verbal, and written communication skillsExperience across multiple therapeutic areas is a plusResults-oriented with the ability to establish priorities, manage competing demands, and deliver against dynamic timelinesFlexible, proactive, and creative approach to problem solvingHighly collaborative team player who promotes open communication and cross-functional partnershipWillingness to travel up to 20% based on business needs