Associate Director, Clinical Quality Assurance

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the Clinical Quality Assurance representative on designated clinical study teams, offering proactive guidance to ensure that the conduct of clinical trials meets GCP and regulatory standards.

• Oversee clinical quality incidents, investigations, and CAPAs, ensuring thorough root cause analysis, corrective measures, and recognition of systemic quality patterns.

• Evaluate quality signals across various studies, vendors, and operational processes to pinpoint emerging risks and suggest mitigation strategies.

• Contribute to the governance of the clinical audit program, including the risk-based selection of audits and supervision of Audit CAPA follow-up. The audit function will execute the audits.

• Act as a quality liaison with CROs and vendor quality representatives to ensure effective management and resolution of quality concerns.

• Assist in inspection readiness activities and provide primary Clinical QA support during sponsor regulatory inspections, covering both preparation and follow-up actions.

• Review and offer input on new or updated SOPs and controlled documents to ensure compliance with regulatory requirements and consistency throughout organizational procedures.

• Provide insights on training assignments and training matrices to ensure that procedures are effectively implemented across different functional roles.

• Engage in process enhancement initiatives that contribute to the development and fortification of the Quality Management System, including the evaluation, assessment, and implementation of quality governance, processes, and systems.

⛳️ Requirements

• A Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline is required. An advanced degree is preferred.

• Approximately 8+ years of industry experience, including leadership in clinical quality oversight or quality governance.

• Strong practical knowledge of global GxP regulations relevant to clinical development, including:

• Good Clinical Practice (GCP)

• Good Pharmacovigilance Practice (GVP)

• Good Laboratory Practice (GLP)

• Experience in the following areas is desired:

• Quality management and oversight of clinical trials

• Management of quality events and CAPAs

• Preparation for regulatory inspections and support during inspections

• Risk-based quality management strategies

• Planning clinical audits (including site and internal audits)

• Developing metrics and analyzing issues for quality signals and trends

• Governance of SOPs through controlled document reviews

• Training matrix or training governance activities

• Relevant certifications such as RQAP, CQA, CCRC, or RAC are considered advantageous.

🏝️ Benefits

• Medical, dental, and vision insurance

• 401k match

• Flexible time off

• Paid holidays

• Annual performance incentive bonus

• New hire equity

• Ongoing performance-based equity