Senior Quality Assurance Regulatory Manager (Winnipeg)

Senior Quality Assurance Regulatory Manager (Winnipeg)

08 Nov
|
Piramal Pharma
|
Winnipeg

08 Nov

Piramal Pharma

Winnipeg

Lead quality assurance and regulatory affairs at Piramal Pharma Solutions in Aurora, guiding cGMP compliance, QMS performance, and risk escalation.The Senior Manager provides leadership for QA, Quality Management Systems, and Regulatory Affairs functions at the Aurora site. Working with the Director, Quality and Regulatory Affairs, this position oversees compliance with cGMP, regulatory, client, and corporate requirements. The role also drives continuous improvement, organizational capability, and accountable quality decision-making.Key Responsibilities: Set objectives, resource priorities, and performance expectations across functionsOversee quality events, investigations, remediation, and risk escalationReview QMS metrics, trends, systemic issues, and improvement actionsApprove or reject APIs,



intermediates, and products for releasePrepare for regulatory inspections and client auditsRequirements: Leadership experience across QA, QMS, and Regulatory AffairsKnowledge of applicable cGMP and regulatory requirementsAbility to assess quality, compliance, and regulatory risksExperience leading teams and developing organizational capabilityAbility to partner across Operations, R&D;, Engineering, and Supply ChainApply senior leadership across cGMP, QMS, batch disposition, and regulatory oversight at Piramal Pharma Solutions Aurora.

📌 Senior Quality Assurance Regulatory Manager (Winnipeg)
🏢 Piramal Pharma
📍 Winnipeg

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