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Deputy Director Operational Quality

SANOFI

This is a Contract position in Toronto, ON posted May 6, 2018.

Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines.

Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases. Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. The Deputy Director, Operational Quality (QO) is responsible for day-to-day shop-floor operational quality and compliance, of licensed products, for designated departments of Industrial Affairs (bulk manufacturing, formulation, filling & packaging, quality control, manufacturing technology, quality operations, media services, sterility assurance and technical services) in compliance with Sanofi Pasteur quality systems requirements and current Good Manufacturing Practices. He/she ensures that compliant and effective processes exist and is accountable for continuous improvement activities and enabling innovation within operational quality. Key Responsibilities Provide leadership of Operational Quality team assuring that processes are executed effectively and compliant and that resources are planned and utilized effectively. Ensure timely (shop-floor) review and approval of deviations, SOPs, CCRs, CAPAs and other GxP documents and reports that are within scope, and ensure that batch decisions are compliance and science-based and supporting reports are of high quality. Recruit, coach, and develop staff to ensure a well trained high performance team that partners with production and operates at the level of competencies and independence of risk-based decision making required to support the ongoing cGMP compliance on the shop floor. Participate and lead self-inspections, periodic internal reviews/audits to ensure compliance procedures are followed and participates in external audits/inspections. Ensure that Operational Quality staff are present and visible on the shop floor and promotes the development and embedding of a culture of quality. Lead and sponsor continuous improvement and innovation activities. Liaise across all Industrial Affairs departments, RA, other Sanofi-Pasteur sites, CROs and health authorities. Required Qualifications Master of Science specializing in Microbiology, Biochemistry, Immunology or Pharmacology Over Eight (8) years of Quality Assurance experience in pharmaceutical or biological manufacturing Strong communication and influencing skills Strong leadership and management capability Excellent knowledge of cGMPs, compliance trends and vast amount of experience with inspections/audits Excellent problem solving, investigation and communication skills Solid experience with continuous improvement methodologies and risk-based approaches Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request. Thank you in advance for your interest. Only those candidates selected for interviews will be contacted. Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Sanofi, Empowering Life