Post-Marketing Quality Compliance Manager

This role leads and develops a team responsible for product quality complaints, post-distribution quality monitoring, and the execution of quality-driven field actions, including recalls and market withdrawals. The manager provides strategic direction, coaching, and performance management to ensure timely, compliant, and effective execution of post-market quality processes while fostering a culture of quality and continuous improvement.ResponsibilitiesPost-Market Surveillance & Data AnalysisManage the end-to-end product quality complaint process from intake through closureAssess complaints for product quality impact, GMP compliance risk, and field action triggersTrend and analyze post-market quality data to identify recurring or systemic issuesIntegrate post-market data into Product Lifecycle Management (PLM), APQR/PQRs, Management Review, and Quality Metrics/KPIsComplaint Handling & InvestigationsProvide Quality oversight of vendors supporting complaint intake or triageEnsure accurate, complete, and timely complaint documentationPerform initial Quality assessments and ensure appropriate complaint classificationEscalate potential adverse events to Pharmacovigilance per established proceduresLead or oversee risk-based investigations that identify root cause, assess scope and recurrence, and are supported by objective evidence and manufacturing historyQuality Risk Management & Field ActionsEscalate critical or high-risk quality issues in a timely mannerIdentify and assess potential recalls, market withdrawals, or correctionsLead quality-driven recalls, including regulatory notifications, documentation, and effectiveness check...