Director, Clinical Quality Assurance

Director, Clinical Quality Assurance

The Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs and commercial products. This role is responsible for developing and implementing risk-based strategies; managing audits, inspections, and vendor oversight; and ensuring global regulatory compliance. This role partners cross-functionally to drive continuous improvement, inspection readiness, and sponsor oversight, while proactively identifying and mitigating quality risks. As a subject matter expert, this role establishes program support to uphold industry best practices and regulatory requirements.

This role is based in Waltham, MA without the possibility of being a remote role.

Primary responsibilities include :

• 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
• Conduct and / or manage the qualification and oversight 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

Education and skills requirements :