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Validation Manager, Formulation and Filling Inspection and Packaging (FFIP)

date posted 09/28/2022
contract type Full time
job id R2662344
location Toronto, Canada

Reference No. R2662344

Position Title: Validation Manager, Formulation and Filling Inspection and Packaging (FFIP) - Vaccines

Department: FFIP Quality

Location: 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:

This position is responsible for providing expertise, quality oversight and guidance with regards to regulatory requirements and best practices related to manufacturing process and equipment qualification.

The candidate will participate in project workstreams, ensure proper execution of validation strategies as well as providing support for the quality processes and procedures. 

Key Responsibilities:

Management of Qualification and Validation 

  • Provide quality oversight for manufacturing process equipment, utilities, automation and computerized system validation activities pertaining to FFIP licensure, start-up and lifecycle management.

  • Review/approve validation deliverables (i.e. URS, specification documents, risk assessment, test strategies, protocols, executed raw data packages, reports, validation plans, SOPs, Equipment registration in SAP) in accordance with internal and regulatory policies.

  • Review, assess and approve change controls, deviations and corrective plans, resulting from validation/qualification studies.

  • As required, represent Quality Operations on project team and/or sub-teams and/or project working groups to provide direction on validation issues with respect to compliance.

  • Responsible for maintaining validation awareness by screening and reporting on significant validation trends and changes through literature reviews, meetings, and peer discussions within the industry.

Support for Internal Compliance Activities

  • Keep updated on new rules and industry regulations, and to define and align internal quality systems with best practices.

  • Provide expertise and guidance with regards to regulatory requirements for manufacturing process systems qualification, as well as quality practices, validation strategies, procedures, and related validation activities.

  • Responsible for identifying opportunity for improvements to quality processes through the review and evaluation of quality metrics and recommending appropriate resolutions.

  • Provide training on Related Activities.

HSE REQUIREMENT/STATEMENT

  • Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.

Major Challenges:

  • Influence stakeholders and team members in order to maintain priority for validation activities.  Support to develop and deliver high quality documentation within limited timeframes in order to align with current regulatory requirements and project commitments defined for FFIP.

  • The Quality Manager 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 ensure on-going alignment to the specific project policies and global policies related to validation and data integrity.

  • The incumbent is expected to provide guidance (or research issues if no guidance is readily available) for quality- or compliance-impacting decisions in the development and implementation of documents and records.

Dimensions/Scope:

  • This role will be part of the B53 FFIP Quality team at Sanofi Pasteur Toronto and will support computerized systems validation activities and manufacturing process equipment qualification activities. The role is an exciting opportunity with B53 FFIP project and requires understanding of the complexity in facility/automation/process/qualification, and effective cross-functional interaction.

Key Requirements:

  • Bachelor’s Degree in Engineering / Science or related field.

  • 4+ years of experience in a GMP controlled environment/pharmaceutical industry is required.

  • Experience with qualification of manufacturing process equipment is required (examples of automation and manufacturing equipment include: Isolators, Fillers, Capper, RABS Fermentors, etc.)

  • Experience with computerized systems validation is a must.

  • Experience with qualification of Delta V, Data Historian OSI PI, and Manufacturing Execution System MES is an asset.

  • Technical writing, effective oral and written communication skills, and strong compliance mindset.

  • Good understanding of current and evolving regulatory requirements.

  • Strong communication, interpersonal skills and teamwork are a must, as individual will be working on cross functional project teams which include members from various organizations within Sanofi Pasteur, such as Bulk Manufacturing, Manufacturing Technology, Engineering and ITS.  Good interpersonal and influencing skills are important for a candidate’s success in this role.

  • Ability to anticipate evolutions due to internal and external factors.

  • Conflict resolution and problem solving.

  • Familiarity with strategic planning, balanced judgment and risk analysis.

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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