Associate Director, Clinical Quality Assurance

Role Overview

• Serve as the Clinical Quality Assurance representative on assigned clinical study teams, providing proactive guidance to ensure clinical trial conduct aligns with GCP and regulatory expectations.
• Provide oversight of clinical quality events, investigations, and CAPAs, ensuring appropriate root cause analysis, corrective actions, and identification of systemic quality trends.
• Analyze quality signals across studies, vendors, and operational processes to identify emerging risks and recommend mitigation strategies.
• Contribute to governance of the clinical audit program, including risk-based selection of audits and oversight of Audit CAPA follow-up. Execution of audits is performed by the audit function.
• Serve as a quality interface with CROs and vendor quality representatives to ensure appropriate management and resolution of quality issues.
• Support inspection readiness activities and provide first-line Clinical QA support during sponsor regulatory inspections, including preparation and follow-up actions.
• Review and provide input on new or revised SOPs and controlled documents to ensure alignment with regulatory requirements and consistency across organizational procedures.
• Provide input on training assignments and training matrices to ensure procedures are appropriately implemented across functional roles.
• Participate in process improvement initiatives that support the development and strengthening of the Quality Management System, including the evaluation, assessment, and implementation of quality governance, processes, and systems.

Requirements

• Bachelor’s degree in life sciences, pharmacy, or related scientific discipline required. Advanced degree preferred.
• Approximately 8+ years of industry experience, including leadership in clinical quality oversight or quality governance.
• Strong applied knowledge of global GxP regulations applicable to clinical development, including:
• Good Clinical Practice (GCP)
• Good Pharmacovigilance Practice (GVP)
• Good Laboratory Practice (GLP)
• GMP experience is not required for this role
• Experience with the following is desired:
• Quality management and oversight of clinical trials
• Quality event and CAPA management
• Regulatory inspection readiness and inspection support
• Risk-based quality management approaches
• Planning of clinical audits (including sites, internal audits)
• Developing metrics and reviewing issues for quality signals and trends
• SOP governance through controlled document reviews
• Training matrix or training governance activities
• Relevant certifications such as RQAP, CQA, CCRC, or RAC are considered a plus.

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• 401(k) matching
• Flexible work hours
• Paid time off
• Remote work options