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Deputy Director, B200 FFIP Quality Operations - Vaccines

Toronto, Canada

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Responsibilities

Reference No. R2617573

Position Title: Deputy Director, B200 FFIP Quality Operations - Vaccines

Department: Validation Systems

Location: Sanofi Pasteur Limited, Toronto

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.

Position Summary:

  • Provide strategic, operational and technical direction across the organization to assure data integrity. Highly experienced in domain areas such as analytical chemistry, automation, data management, change control, project management, lab operations,  cGMP and pharmaceutical regulatory compliance, and new and emerging technologies.   
  • In-depth experience in data integrity assurance, 21 CFR Part 11, Health Canada & EU Annex 11 compliance.   
  • Accountable for ensuring all shop-floor personnel are adequately managed, trained and equipped to support engineering, validation and future manufacturing operations to de-risk their success.
  • Build and maintain a high performing team, providing effective alignment and communication with functional groups at the site and at other manufacturing sites, to successfully deliver on the required commitments. 
  • Provide input into the strategic direction of the SQO organization ensuring the requirements of FFIP are adequately factored in.
  • Provide guidance and technical support the department staff in the delivery of validation studies linked to equipment, process, and test method validation including project planning.
  • Support/lead troubleshooting of complex issues encountered during CQV activities. In addition, lead/coordinate CQV deviations and change management.
  • Review and influence the future of operational and quality systems (i.e. deviation and change management, batch management, validation, training etc.) to ensure Quality 4.0 / Pharma 4.0 principles are embedded into their evolution.
  • Supervise staff and manage risk in accordance with company commitment and appropriate policies and procedures. 
  • Provides the coaching, training, and development necessary to enhance the competencies, skills, knowledge and expertise of the individuals that report directly. 
  • Provide expertise and support to regulatory inspections including quality representation on all activities / topics involving Quality.
  • Develop, lead and manage the execution of quality and operational transition plans; ensure a detailed lesson learned is executed, documented and disseminated to respective personnel upon project closure.
  • Develop and manage the execution of the validation and future audit readiness plan; ensure the readiness plan factors all potential risks associated with the project (i.e. facility, processes, personnel etc.) to ensure a successful Health Authorities Inspections.
  • Represent quality in cross-functional meeting/project; recruit, develop and lead personnel to ensure department and project objectives are met (i.e. quality, safety, cost).
  • Ensure timely resolution and/or escalation of quality issues to senior management.

Key Responsibilities:

  • Build and maintain a high performing team, providing effective alignment and communication with functional groups at the site and at other manufacturing sites, to successfully deliver on the required commitments. 
  • Provide oversight for the governance, management and coordination of activities related to the Quality Operations linked to the Formulation Filling Inspection and Packaging Operations (FFIP).
  • This position is responsible for leading the Site Quality Operations teams within the Formulation Filling and Packaging facility (FFIP) project.
  • The objective of this function will be to ensure the project is delivered from design to licensure while following current GxP, corporate, regulatory and industry best practices.  Additionally, this role will be responsible for supporting Commissioning, Qualification & Validation (CQV) activities which occur as part of the facility start up.
  • The incumbent will manage direct reports and provide quality and technical direction to multi-functional teams while actively participating in driving and developing strategies for continuous improvement within manufacturing and quality.
  • The overall objective of this role will be achieved through the development and execution of quality and operational transition plans. The position will be required to liaise with process owners to work through the FFIP facility integration strategy; additionally, the corresponding evolution of the respective quality and operational processes to support future operations within the facility will be managed.

Key Requirements:

  • Minimum Bachelor’s Degree in Science/Engineering or a related field with  7-10 years of experience or combination thereof in a biopharmaceutical environment and in-depth knowledge of the biologic product license application process, and the associated regulatory requirements is mandatory.
  • Working knowledge of Production shop floor systems and processes.
  • In-depth knowledge of the principle discipline - validation and biopharmaceutical industry compliance and data integrity assurance (i.e cGXPs, 21 CFR Part 11 & EU Annex 11, current industry standards and practices, and process/environmental engineering).
  • Working knowledge and hands-on experience with production processing including automation, scientific writing, effective oral and written communication skills, and innovative thinking.
  • Appropriate certifications and professional affiliations to ensure continuous learning and incorporation of c-GMPs.
  • Strong problem solving and decision-making skills / tools to resolve issues in a manner that is customer focused; but without compromise to making good quality decisions.
  • Ability to understand role's impact and influencing skills∙ Diverse business, quality, and industrial manufacturing knowledge base.
  • Strong managerial, organizational, human-relations/interpersonal skills, excellent written and verbal communication skills.
  • High level of computer literacy, training and coaching skills.
  • Excellent analytical skills, good understanding of statistical and problem solving techniques, multi-task capability.

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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