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 functions

Oversee quality events, investigations, remediation, and risk escalation

Review QMS metrics, trends, systemic issues, and improvement actions

Approve or reject APIs,



intermediates, and products for release

Prepare for regulatory inspections and client audits

Requirements

Leadership experience across QA, QMS, and Regulatory Affairs

Knowledge of applicable cGMP and regulatory requirements

Ability to assess quality, compliance, and regulatory risks

Experience leading teams and developing organizational capability

Ability to partner across Operations, R&D;, Engineering, and Supply Chain

Apply senior leadership across cGMP, QMS, batch disposition, and regulatory oversight at Piramal Pharma Solutions Aurora.

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