Senior Quality Assurance Regulatory Manager

Lead Quality Assurance and Regulatory Affairs at Piramal Pharma Solutions in Aurora, guiding QMS compliance and risk-based quality decisions.As Senior Manager, you will direct QA, Quality Management Systems, and Regulatory Affairs at the Aurora site. You will work with the Director, Quality and Regulatory Affairs, and cross-functional leaders to maintain cGMP, regulatory, client, and corporate compliance. The role emphasizes effective programs, continuous improvement, inspection readiness, and organizational capability.Key Responsibilities:
Lead QA, QMS, and Regulatory Affairs functionsOversee quality events, investigations, risks, and remediationDirect QMS metrics, trends, and improvement prioritiesApprove or reject batches within delegated authorityPrepare teams for inspections and client auditsRequirements:
Leadership across Quality Assurance and Regulatory AffairsExperience with cGMP and quality compliance requirementsAbility to assess and escalate significant risksCapability to lead, coach, and develop employeesExperience supporting cross-functional quality decisionsApply senior leadership in QA, QMS, regulatory compliance, and quality risk management at Piramal Pharma Solutions.
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