Nirali N.
Manager, Quality & Compliance @Sunovion Pharmaceuticals
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WORK HISTORY
Manager, Quality & Compliance @Sunovion Pharmaceuticals
ON, CA
Managed Quality Systems and documentation to ensure compliance with Health Canada regulations for pharmaceutical imports and distribution. • Developed and maintained Standard Operating Procedures (SOPs) and a comprehensive GMP Training Program. • Supervised compliance of third-party contract manufacturers and conducted audits to uphold quality standards.
EDUCATION
University of Toronto Scarborough
Hon. BSc., Life Science
American Society of Quality
Certified Quality Auditor
University of Toronto Scarborough
Bachelor of Applied Science - BASc
ABOUT NIRALI N.
Quality & Compliance leader with 20+ years of experience in the pharmaceutical industry, specializing in Quality Systems, GMP compliance, Risk Management, Inspection Readiness, and Deviation/CAPA governance across global organizations.I provide strategic leadership in building and strengthening QMS frameworks, ensuring regulatory alignment (Health Canada, FDA, etc.), and driving cross-functional accountability. My experience includes oversight of deviation and CAPA programs, change control, audit support, and continuous improvement initiatives across diverse product portfolios.Known for clarity, structure, and a steady approach, I partner effectively with QA, RA, QC, Operations, and external consultants to deliver compliant, sustainable quality outcomes. My strength is leading through influence — aligning teams, guiding decision-making, and supporting a culture of quality excellence.I’m seeking roles in Quality Assurance, Quality Systems, Compliance, or Quality Governance where I can contribute strategic oversight, enhance inspection readiness, and elevate QMS performance.
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