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Shop Floor Manager, Operational Quality - Weekend/Nights - Toronto, ON

Toronto, Canada

Sanofi, in the U.S. and Canada, strives to create a diverse and inclusive work environment that empowers employees to drive their careers and be successful. The talent we look for will contribute to the organization in innovative, insightful, and creative ways in order to strengthen our dynamic culture and drive us collectively to make a difference in the lives of patients.

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  • HEALTH AND WELLNESS PROGRAMS

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • EMPLOYER MATCHING

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  • PROFESSIONAL DEVELOPMENT

    Sanofi is eager to further your development and expertise in an ever challenging environment.

  • FAMILY SUPPORT

    Sanofi understands the importance of family. We offer a variety of support including maternity/paternity leave.

  • PAID TIME OFF

    Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!

  • WORK/LIFE BALANCE

    Importance of life outside of the office is valued at Sanofi.

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Responsibilities

Position Title: Shop Floor Manager, Operational Quality - Weekend/Nights

Site/Department: Toronto / Quality Operations Operational Quality

WORK SHIFTS

  • Thursday from 12:00am-8:00am EST
  • Friday from 12:00am-8:00am EST
  • Saturday from 12:00am-8:00am EST
  • Sunday from 12:00am-8:00am EST
  • Monday from 12:00am-8:00am EST

Mission:

The Shop Floor Manager, Operational Quality is responsible for providing Operational Quality support to Industrial Affairs.  The incumbent will report into a Deputy Director and will generally support a specific department, though will be responsible for support in other departments as necessary.  The incumbent is expected to work independently and with a level of autonomy and authority in decision-making as a delegate to the Deputy Director as necessary to drive process improvements, ensure on-going compliance against approved documents and current Good Manufacturing Practices. 

As a member of the Operational Quality team, the incumbent will be expected to manage work load distribution to ensure a satisfactory level of performance and customer satisfaction.  This team will perform document review, non-conformance investigations, process change requests, support quality improvement, participate on project teams, support self inspection and promote a strong quality culture on the manufacturing shop floor and a state of inspection readiness at all times.  Operational Quality oversees all activity on the shop floor, so a strong sense of involvement and ownership in the department is necessary for success. 

Key Accountabilities:

  • Ensure timely review and approval of logbooks, batch documentation, SOPs, Change Controls, CAPA, protocols, and other GxP documents and reports that are within scope or delegated.
  • Coach, develop and motivate staff to ensure a well-trained, high-performance team operating at the level of competencies and independence of decision making required to support the ongoing cGMP compliance of the shop floor.
  • Provide guidance and leadership on quality issues on a daily basis to the support groups.

Support the Quality Activities for the area of responsibility as follows:

  • Ensure deviations are processed and that problem resolution occurs prior to commitment date within the GMP tracking system.
  • Ensure that batch disposition recommendations are based on sound science and supporting reports are of high quality.
  • Ensure timely review and approval of deviations of all category levels.
  • Provide Operational Quality (OQ) support through shop floor presence and knowledge transfer, to ensure that there is in-depth understanding of specific operations and that issues are identified and addressed through standard site ways-of-working.

Support the OQ Deputy Director as back-up in:

  • Review and approval of deviations.
  • Review and approval of CAPA plans.
  • Assessing and approving Process at Risk (PAR) forms.
  • Financial provisioning of batches in event of batch loss.

Education and Experience:

  • Bachelor of Science specializing in Microbiology, Biochemistry, Immunology or Pharmacology (or B.Eng)
  • Minimum 5 (five) years of GMP experience in pharmaceutical or biological manufacturing
  • Strong communication and influencing skills
  • A highly capable problem-solver
  • A commitment to keeping up-to-date on regulatory and compliance trends
  • Strong leadership and management capability

Sanofi Pasteur: The world’s leading vaccine company

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.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, 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, Empowering Life

#GD-SP #LI-SP

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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