Primary responsibilities include: * Understanding GXP requirements such as (but not limited to) GCP, GVP, GMP, GDocP etc. and implementing/ monitoring them for QA function, as applicable. * Facilitating the process of initiation of investigations and CAPAs, monitor progress and perform reviews/approvals including stakeholder management for closure of CAPAs. * Ensuring that CAPA procedures and requirements are followed and met. Uphold standards for quality and compliance in pharmacovigilance. * Performing QA functions pertaining to (but not limited to) Change management, CAPA, Deviation, Internal Audits, External Audits, Risk management, Innovation and Continual improvement. * Escalating and involve stakeholders for resolution as needed, issues impacting the progress toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records. * Reviewing evidence and approve closure of CAPA plans and effectiveness monitoring plans. * Facilitating regular CAPA status and metric reports to ensure senior management awareness. * Participating in governance/oversight activities including trend assessment or other quality review. * Knowledge in the area of Clinical Operations is preferred. Mandatory Skills: * Quality Assurance * Nonconformance management (CAPA, Deviations, Issues) Preferred Skills: * GCP * Stakeholder management * Conflict Resolution * Problem Solving