Senior Quality Assurance Regulatory Manager

Lead Quality Assurance and Regulatory Affairs at Piramal Pharma Solutions’ Aurora site, directing QMS priorities, compliance oversight, and quality decision-making.This Senior Manager provides leadership across QA, Quality Management Systems, and Regulatory Affairs. The position maintains compliance with cGMP, regulatory, client, and corporate requirements while addressing significant risks. It also drives continuous improvement and organizational capability.Key Responsibilities:
Direct QA, QMS, and Regulatory Affairs objectives, resources, and performance expectationsOversee quality programs, investigations, metrics, trends, and continuous improvementExercise delegated authority for significant quality and compliance mattersApprove or reject APIs, intermediates, and products for releasePrepare organizational readiness for regulatory inspections and client auditsRequirements:
Leadership experience across Quality Assurance, QMS, and Regulatory AffairsKnowledge of applicable cGMP, regulatory, client, and corporate requirementsAbility to assess, escalate, and remediate significant quality risksExperience leading, coaching, and developing functional employeesCapability supporting workforce planning and departmental budget managementShape quality leadership at Aurora through compliance oversight, regulatory readiness, QMS effectiveness, and risk-based decision support.
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