Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management

Key Responsibilities

• Audit Planning, Preparation, Conduct and Reporting: Operationalize approved audit plans and strategies for R&D GCP audits (External & Internal audits), considering relevant regulations and industry standards; Coordinate audit schedules and necessary resources with relevant stakeholders: Review documentation, procedures, and quality management systems prior to conducting audits.

• Perform on-site or remote audits (routine, for-cause/directed); Evaluate compliance with GCP regulations, internal quality standards, and relevant guidelines; Document audit findings, deviations, and areas of non-compliance; Interview personnel, review records, and gather evidence during audits.

• Prepare comprehensive audit reports outlining findings, observations, and recommendations for corrective actions; Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures and e...