Director, Clinical Quality Assurance

Summary of Key Responsibilities

• Inform and contribute to audit planning and strategy
• Perform and/or coordinate clinical site and vendor audits
• Oversee deviations, quality issues (QIs), CAPAs, effectiveness checks, root cause analyses, and associated KPIs
• Advise internal stakeholders and external partners on GCP compliance matters and identify emerging non-compliance trends
• Support inspection readiness activities and co-host regulatory inspections
• Develop and deliver GCP-related training; contribute to the creation, revision, and maintenance of policies, SOPs, and work instructions in alignment with global regulatory requirements
• Coverage of service providers
• Ensure service providers adhere to quality programs and applicable regulations, maintaining inspection readiness
• Assess and escalate compliance risks identified through audits to protect subject safety, data integrity, and business continuity
• Lead or support the preparation for and response to regulatory audits and inspections, ensuring adherence to requirements and timely resolution of findings
• Support investigational new drug (IND) applications and related correspondence with global regulatory authorities

Qualifications

• Bachelor’s degree with 12+ years of related experience preferably in life sciences with 8+ years of experience in a Clinical Quality Assurance role, or an equivalent combination of PV and QA experience
• Deep knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP, GxP), including safety reporting requirements
• Broad clinical development experience across all phases (Phase I through BLA/NDA)
• Strong understanding of GCP quality principles spanning preclinical, clinical, and commercial stages
• Proven experience developing and implementing risk-based clinical quality assurance programs
• Demonstrated success leading clinical site and supplier audits, managing regulatory inspections, and responding to findings
• Skilled at effectively communicating quality events and outcomes to internal stakeholders
• Excellent interpersonal, verbal, and written communication skills (must have)
• Working knowledge of multiple therapeutic areas is a plus
• Results-oriented, with the ability to set clear objectives, manage competing priorities, and meet dynamic timelines
• Flexible and creative problem solver with a proactive mindset
• Highly collaborative team player who fosters open communication and cross-functional cooperation
• Willingness to travel up to 20% based on business needs