Executive Director, Clinical Quality Assurance, R&D Quality

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The Executive Director, Clinical Quality Assurance is a key leader on the R&D Quality Leadership Team responsible for leading the Clinical Quality Assurance function and ensuring the highest standards of quality and compliance in clinical research and related activities.  The role is responsible for developing and implementing quality assurance strategies, including therapeutic area, process, and vendor audit and inspection strategies to ensure compliance with regulatory requirements and company standards. 

The Executive Director will work closely with cross-functional teams to support clinical development and ensure the integrity and quality of clinical data and clinical trial subject safety.  This leader will sit on key functional area leadership team(s) and also chair key clinical quality councils.  In addition, the Executive Director will provide credible compliance advice and guidance as well as manage and communicate quality and compliance risks and mitigations to respective management boards.  This role is a key contributor in advancing our overall Global Quality vision and strategy.

Key Responsibilities

• Lead the Clinical Quality Assurance function, providing strategic direction and oversight.
• Develop, implement, and maintain quality assurance policies, procedures, and systems to ensure compliance with GCP, ICH guidelines, and regulatory requirements.
• Translate risk factors into clinical quality assurance oversight plans, including internal and external audit strategies and inspection readiness/management strategies.
• Oversee the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and proceses/systems, including for-cause and directed activities.
• Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to Health Authorities, business partners and senior management
• Lead vendor quality oversight activities and manage external quality (e.g. quality agreements with CROs, set vendor quality councils, etc.)
• Develop quality strategies for new clinical trial technology and approaches (e.g., decentralized trials, real world evidence, digital health, etc.)
• Oversee the development and maintenance of an effective inspection management framework supporting clinical trials.
• Provide leadership and oversight for GCP Inspections ensuring effective readiness, preparation, management, and response development and action closure.
• Ensure timely identification, investigation, and resolution of quality issues and non-compliances.
• Partner with RBQM in the development of the Quality Narrative, specifically developing and contribution the audit/inspection portion.
• Collaborate with Drug Development and other departments to support clinical programs and ensure quality and compliance.
• Engage with executive management and cross functional business partners to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement, drive issue resolution
• Provide leadership, guidance, development and coaching to the CQA team, fostering a culture of quality and continuous improvement.
• Ensure CQA team are trained and qualified to perform audit and inspection related activities.
• Attract, develop, and retain high quality talent within the organization.
• Monitor and interpret regulatory trends and changes, and ensure the company’s clinical quality systems are updated accordingly.
• Represent the company in interactions with regulatory agencies.
• Develop and deliver training programs to enhance quality awareness an