Senior Quality Systems And Regulatory Manager

Shape QMS performance, regulatory oversight, and compliance risk management for Piramal Pharma Solutions at its Aurora site. Lead quality functions through effective governance and accountability.As Senior Manager, Quality Assurance and Regulatory Affairs, you will direct QA, QMS, and Regulatory Affairs activities. The position emphasizes quality metrics, systemic risk, data integrity, electronic compliance, supplier quality, and regulatory requirements. You will work with the Director, Quality and Regulatory Affairs and cross-functional leaders to drive sustainable improvements.Key Responsibilities:
Ensure effective, compliant quality systems and programsAddress systemic issues, trends, and compliance risksOversee data integrity and electronic complianceManage supplier quality risks and remediationIncorporate regulatory considerations into site changesRequirements:
Leadership experience within QA, QMS, and Regulatory AffairsUnderstanding of quality metrics, trends, and risk assessmentAbility to oversee significant investigations and root-cause determinationKnowledge of licensing requirements and regulatory activitiesAbility to provide senior quality decision supportBring QMS governance, regulatory judgment, and compliance risk leadership to Piramal Pharma Solutions’ Aurora operations.
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