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Director, Shop-floor Operational Quality - Toronto, Ontario

Toronto, Canada

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Overview

This is where ideas are pioneered and innovation takes shape. Where being a health journey partner takes shape — and where you can help bring ideas to life. Research & Development is the heart of our business. The clinical research, clinical development and clinical trials that are essential to new product development all happen here. Preclinical drug safety is rigorously tested and our program management teams ensure everything stays on track. Together, our R&D team ensures that our pipeline is protected and productive — and that the early stages of development run smoothly and effectively. Come be part of this journey.

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Benefits

  • Health & Wellness

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

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

  • Culture

    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

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Quote

"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."

C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic

"I am continually impressed at the dedication that Sanofi has to the patients for whom we provide solutions."

Suncére Hernandez Area Business Manager, Multiple Sclerosis

"I give thanks to my powerhouse team for reminding me that I have a support system behind me, pushing me forward."

Bob Shustack Head of Global Support Functions Finance, North America

Responsibilities

Position Summary:

The Director, Operational Quality provides leadership to the Operational Quality Team. The incumbent is accountable and responsible for day-to-day shop-floor operational quality and compliance for designated departments of Industrial Affairs (e.g., formulation,  filling & packaging, quality control, manufacturing support departments various, bulk manufacturing platforms, etc) in compliance with Sanofi Pasteur quality systems requirements and current Good Manufacturing Practices. 

The scope of a Director’s authority has the same breadth as the platform Director(s) s/he supports, including oversight of any and all activities that directly or indirectly impact or influence the shop floor.  S/he defines competencies, coaches, develops and set objectives for his or her team. The incumbent is expected to work independently with a high level of autonomy and authority for decision making. S/he ensures that compliant and effective processes exist and is accountable for continuous improvement activities and enabling innovation within operational quality.

While this role will directly support key production platforms on site, the Director of Operational Quality will also serve as the first point of escalation for all platforms supported by OQ.  S/he will develop and maintain communication and escalation channels for all Quality units within OQ to ensure responsive support is provided throughout site operations.

Key Accountabilities:

  • Serves as the principle delegate for Sr. Director, Operational Quality, routinely driving departmental business and projects. 
  • 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.
  • The incumbent is the direct manager of OQ staff that supports late stage production and support areas (formulation, filling, labeling, packaging, Quality Control and other areas). 
  • Provides leadership of Operational Quality team assuring that processes are executed effectively and compliant and that resources are planned and utilized effectively.  Ensures systems are in place and workload is managed appropriately to provide timely (shop-floor) review and approval of deviations, SOPs, CCRs, CAPAs and other GxP documents and reports that are within scope, and ensures that batch decisions are compliance- and science-based and supporting reports are of high quality.
  • Serves as the key point of contact for Quality Operations during self-inspections, periodic internal reviews/audits, and external audits/inspections.
  • Ensures that Operational Quality staff are present and visible on the shop floor and promotes the development and embedding of a culture of quality.
  • Leads and sponsors continuous improvement and innovation activities.

Education and Experience:

  • Bachelor of Science or Master of Science, or equivalent combination of education and experience in pharmaceutical and/or biological manufacturing
  • Minimum 15 years of biological / sterile pharmaceutical production experience
  • Proven track record of increasing levels of responsibility throughout his/her career
  • Direct supervisory experience is strongly preferred
  • Experience with direct interaction with Regulatory Agencies preferred

Key Technical Competencies and Soft Skills:

  • A broad understanding of Quality responsibilities is necessary, including shop floor support, sterility assurance, Commissioning & Qualification / validation, product / material controls (including market release), and QC testing.
  • 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 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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