Hari Sathasivam
Operational Quality Manager @Sanofi
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WORK HISTORY
Operational Quality Manager @Sanofi
Toronto, ON, CA
Directed shop-floor Quality oversight for large-scale production of cellular pertussis (cP) antigens, diphtheria, and tetanus, leading cross-functional Operations teams and making real-time Go/No-Go decisions to uphold product quality and regulatory compliance. • Championed timely closure of deviations, Corrective and Preventive Actions (CAPAs), and change controls, coaching Operations and technical staff on root cause analysis while reinforcing a culture of compliance and accountability. • Led impact assessments for complex change controls across processes, equipment, automation (DeltaV distributed control systems), raw materials, and documentation, guiding cross-functional stakeholders to ensure compliant, validated, and inspection-ready operations. • Provided Quality leadership during Aseptic Process Simulation Studies (APSS), collaborating with Operations and Sterility Assurance teams to strengthen aseptic practices and maintain global inspection readiness. • Oversaw review and approval of electronic Master Batch Records (eMBRs) in the Manufacturing Execution System (MES), partnering with Operations, Automation, and IT functions to align workflows in SAP and content management systems for compliant, efficient batch release. • Directed authorship and authorization of GMP documentation (Standard Operating Procedures, master batch records, controlled procedures), leading Operations and Quality teams in harmonizing standards across the site. • Mentored and developed Quality and Operations staff, fostering cross-functional knowledge-sharing and building a strong pipeline of future leaders in compliance and manufacturing support. • Partnered with senior site leadership to shape organizational Quality strategy, aligning operational execution with corporate compliance goals, global regulatory expectations (Health Canada, FDA, EMA), and continuous improvement initiatives.
EDUCATION
Toronto Metropolitan University
Master's of Applied Science (MASc), Applied Microbiology / Molecular Biology
Ryerson University
Honors Bachelor of Science (BSc), Biology
ABOUT HARI SATHASIVAM
Biotech Specialist and Researcher | Lab Manger | Science Communicator I\'ve been deeply immersed in the world of research and innovation, merging technical expertise with a passion for science communication. Whether delving into data analysis, ensuring a compliant environment, or navigating challenges, my enthusiasm stems from a genuine love for problem-solving, process optimization, and connecting with people.
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