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 (Aurora)
🏢 Piramal Pharma
📍 Aurora