Executive Director, Clinical Quality Assurance

Bachelors + 17 or Masters + 15 or PhD + 10 years of related experience Extensive expertise in GCP, GPvP, GLP and ICH clinical requirements, clinical development and methodologies of clinical studies.

Successful track record of translation and implementation of clinical requirements into operational execution.

Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.

A successful track record of working with service providers and CROs.

Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.

Ability to tactically and strategically execute the day-to-day operations to support clinical trials and clinical and non-clinical development activities.

The Executive Director, Clinical Quality Assurance (CQA) will be responsible for all aspects of Quality Assurance focused on Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GPvP) and Good Laboratory Practices (GLP) activities to ensure quality assurance and compliance of Jade sponsored clinical trials with applicable regulations, ICH guidelines, OECD Principles of GLP, Jade procedures and policies, and current industry standards and practices.

The Executive Director, Clinical Quality Assurance will perform day-to-day clinical quality operations and compliance activities to support the success of our clinical programs in addition to being a strategic partner to Clinical Development and Operations. This role will maintain and ensure effectiveness of quality programs and documentation to assure compliance and inspection readiness with all applicable quality requirements and regulatory standards. The ideal candidate brings hands-on expertise in GCP, GPvP and GLP QA operations, a proactive approach to problem-solving, and the ability to guide and influence cross-functional teams while upholding the highest standards of quality and compliance.

Provide hands on clinical QA oversight and review of protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents.

Provide coaching, Quality decisions and be Quality approver to study teams on protocol deviations, vendor oversight, CAPAs, and issue management.

Act as the primary GCP/GPvP/GLP QA subject matter expert and point of contact for all related matters and issues.