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 expectations

Oversee quality programs, investigations, metrics, trends, and continuous improvement

Exercise delegated authority for significant quality and compliance matters

Approve or reject APIs, intermediates, and products for release





Prepare organizational readiness for regulatory inspections and client audits

Requirements

Leadership experience across Quality Assurance, QMS, and Regulatory Affairs

Knowledge of applicable cGMP, regulatory, client, and corporate requirements

Ability to assess, escalate, and remediate significant quality risks

Experience leading, coaching, and developing functional employees

Capability supporting workforce planning and departmental budget management

Shape quality leadership at Aurora through compliance oversight, regulatory readiness, QMS effectiveness, and risk-based decision support.

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