Deputy Director, B200 FFIP Quality Operations – Vaccines

Job type: Full-Time
Accepting BioReady™: Yes
Category: Senior Management
Education: Bachelor
Experience: 7-10 Years
Employer: Sanofi
Location: Toronto, ON
Posted: January 14, 2022
Closes: February 14, 2022

Job description:

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.
  • Manage and direct a multi-disciplinary team involved in the validation of equipment and processes.
  • 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.
  • Ensuring appropriate competencies are in place to provide a continuously improving, efficient, innovative scientific resource.
  • Provides the coaching, training, and development necessary to enhance the competencies, skills, knowledge and expertise of the individuals that report directly.
  • Conduct regular performance appraisals and provide career development reviews and opportunities for staff.
  • Provide expertise and support to regulatory inspections including quality representation on all activities / topics involving Quality.
  • Operations linked to the manufacturing process or environment.
  • Establish departmental objectives to align with site objectives for safety, quality, productivity, cost, and continuous improvement.
  • Responsible for all local communication reports and updates including develop and maintain departmental operating expense budgets.
  • 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.
  • Serve as QO designate in the review and approval of change controls. Where needed, participates with Change Control Committee in the review of CCR according to sanofi pasteur policies and procedures for equipment, utility and thermal validation. Ensures and verify compliance to Regulatory and Corporate validation standards and policies.
  • Leveraging Pharma 4.0 principles, this position will ensure appropriate quality systems and operational processes are developed, implemented and maintained to ensure the seamless start-up and routine operation of the facility.
  • Raise compliance and quality issues and solutions/proposals to the Quality Lead (Director Validation). Develop, maintain and control departmental capital and operating expense budgets. Responsible for training new and/or existing colleagues on specific procedures/processes when identified and/or designated by Department Head.
  • Responsible for working with user/system owner to perform validation(s) as per designated validation protocols and to critically evaluate the results to determine if they adequately meet the acceptance criteria. Describe the methods required, provide the acceptance criteria and include a rationale for these choices.
  • Supervise and monitor compliance with employment and health and safety legislation to ensure that employees work within the policies, procedures and regulations applicable to their work.
  • Participate in the investigation of incidents and work-related illnesses.
  • Respond promptly to all health and safety concerns or incidents and completes the appropriate documentation in a timely manner.
  • Take every reasonable precaution to ensure the health and safety of staff.
  • Ensure that protective equipment and clothing required is used by staff.
  • Cooperate and assist the Joint Health and Safety Committee in carrying out its functions.
  • Advise staff of any potential or actual health and safety hazard of which they are aware.
  • The incumbent will make decisions regarding the required Quality driven activities and interpretation of cGMPs and industry guidance to achieve required compliance levels.
  • Thorough knowledge of manufacturing, production and testing processes and utilization of quality metrics.
  • Strong communication and influencing skills, problem solving, regulatory and compliance trends, strong leadership and management capability.
  • Position has a high degree of autonomy and is expected to make decisions and interpretations within broadly defined requirements.
  • This position must interact successfully with the fast-paced project teams and have a good understanding of project management.
  • Ability to collaborate and lead cross-functionally to help drive continuous improvement and promote knowledge sharing and endorsement of best practices.
  • Demonstrate the ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives.
  • Excellent interpersonal skills, including written and verbal communication.
  • Strong analytical and balanced decision-making skills – ability to work independently and to make decisions based on experience.
  • Excellent team player attitude.
  • Ability to manage competing priorities.
  • Ability to balance priorities and resources.

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.
  • Familiarity with strategic planning, balanced judgment and risk analysis.
  • Strong communication and influencing skills, problem solving, regulatory and compliance trends, strong leadership and management capability.
  • Appropriate certifications and professional affiliations to ensure continuous learning and incorporation of c-GMPs.
  • Superior knowledge and understanding of quality, cGMPs, regulatory compliance intelligence, current quality and regulatory compliance trends.
  • This position must interact successfully with the fast-paced project team and have a good understanding of project management.
  • 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.

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