Associate Director, Clinical Quality Assurance

Role Summary

The Associate Director, Clinical Quality Assurance provides expert guidance on Good Clinical Practice (GCP) compliance and quality oversight for clinical studies. This role supports the development and maintenance of the Quality Management System, ensures proper documentation and resolution of quality events, and leads process improvement initiatives. Responsibilities include reviewing clinical trial documents, planning and/or conducting internal and external audits, and supporting regulatory inspections.

Responsibilities

• Provide Clinical Quality Assurance (GCP) Subject Matter Expertise (SME) to QED clinical study teams
• Work closely with clinical study teams to ensure/coordinate appropriate documentation of quality event management, including corrective action and preventive action (CAPA) plans
• Support the management, maintenance, and evaluation of QED's Quality Management System and processes for continuous improvement
• Lead small-scale process improvement projects, as needed
• Provide clinical quality assurance SME review of clinical protocols, and other clinical trial-related documents
• Plan, conduct, and/or assist in internal and external service provider audits. Review audit reports, and any corresponding corrective and preventative actions for adequacy
• Provide support for audits and inspections conducted by external sources (e.g., health authorities) as applicable
• Provide support for quality metrics and performance indicators to monitor the effectiveness of clinical quality assurance activities
• Other duties as assigned or required

Qualifications

• Bachelor's degree in a scientific discipline or equivalent experience
• Minimum of 10 years of experience in a GCP practice area; Clinical Quality Assurance or similar role preferred
• Knowledge of applicable GCP guidelines (e.g., CFRs and ICH)
• Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and external vendors
• Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
• Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges
• Attention to detail and proper use of tools for information processing and electronic quality management systems

Skills

• GCP, CFRs, ICH knowledge
• Quality event management, CAPA
• Quality Management System, audits, inspections
• Documentation review and regulatory compliance
• Process improvement

Education

• Bachelor's degree in a scientific discipline or equivalent experience

Additional Requirements

• Travel: On-site visits as needed (quarterly or as required to San Francisco Office)