Director, Clinical Quality Assurance

Boston, MA

A 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 Responsibilities

• Inform and contribute to clinical audit planning and strategy
• Perform and/or coordinate clinical site and vendor audits
• Oversee deviations, quality issues, CAPAs, effectiveness checks, root cause analyses, and related KPIs
• Advise internal stakeholders and external partners on GCP compliance and identify emerging compliance trends
• Support inspection readiness activities and regulatory inspections
• Develop and deliver GCP-related training and contribute to the development, revision, and maintenance of policies, SOPs, and work instructions
• Conduct and/or manage qualification and ongoing oversight of service providers
• Ensure service providers adhere to quality programs and applicable regulatory requirements
• Assess and escalate compliance risks related to subject safety, data integrity, and business continuity
• Lead or support preparation for and responses to regulatory audits and inspections, including timely remediation of findings
• Support IND submissions and related correspondence with global regulatory authorities
• Identify opportunities for process improvement and drive continuous improvement across clinical quality activities
• Perform other duties as assigned

Qualifications

• Bachelor’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 experience
• Strong knowledge of global regulations and guidelines, including FDA, EMA, ICH, GxP, and applicable safety reporting requirements
• Broad clinical development experience across Phase I through NDA/BLA
• Strong understanding of GCP quality principles across clinical development
• Proven experience developing and implementing risk-based Clinical Quality Assurance programs
• Demonstrated success leading clinical site and vendor audits, supporting regulatory inspections, and managing responses to findings
• Strong ability to communicate quality events, risks, and outcomes to internal stakeholders
• Excellent interpersonal, verbal, and written communication skills
• Experience across multiple therapeutic areas is a plus
• Results-oriented with the ability to establish priorities, manage competing demands, and deliver against dynamic timelines
• Flexible, proactive, and creative approach to problem solving
• Highly collaborative team player who promotes open communication and cross-functional partnership
• Willingness to travel up to 20% based on business needs