Manager Computerized System Validation (CSV)

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City : Toronto

Category : Quality, R&D

Industry : Pharmaceutical

Employer : Sanofi

Manager Computerized System Validation (CSV)

Reference #: R2497529

Department: Quality Operations Validations Systems

Location: Toronto, Ontario

About Sanofi Pasteur

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 and guidance with regards to regulatory requirements for computerized systems validation and overseeing quality practices related to Drug Substance and/or Drug Product Vaccine manufacturing. The candidate will participate, lead and or execute validation strategies as well as providing support for the quality processes and procedures.  Review and approve validation documentation in accordance with internal and regulatory policies.  These are achieved through management and execution of a site validation master plan and the review and approve of all applicable validation deliverables. Manage and lead system periodic review to ensure the systems have been maintained in a validated and controlled state, and remain in compliance with regulatory requirements, and continue to meet company policies and procedures.

Major Responsibilities:

  • Provide expertise and guidance with regards to regulatory requirements for validation of Information Technology & Solution (ITS) computerized systems and quality practices.
  • Provides decisions, guidance, and recommendations pertaining to computerized systems, strategies, procedures, and validation activities.
  • Provide interpretations of regulatory guidelines and regulations for validation of computerized systems.
  • Participates, leads and or executes validation strategies as well as providing support for the quality processes and procedures.    
  • Support validation of site computerized systems, and provide validation expertise and guidance to project teams for computerized systems using a risk based approach along project and system life cycle.
  • Support operation & maintenance phase of computerized systems to ensure computerized systems are maintained in a validated state.
  • Maintain site computerized system inventory list and ensure it is current, accurate and complete reflecting the system status.
  • Manage and lead system periodic review to ensure the systems have been maintained in a validated and controlled state, and remain in compliance with regulatory requirements, and continue to meet company policies and procedures.
  • Review, assess and approvals of change controls, corrective plan and deviations as required.
  • Participate in audits of internal and external system providers for GxP compliance as required.
  • Provide audit and inspection support and coordination for system validation related requests.

Education & Certifications:

  • A degree in Engineering / Science combined with 5 to 7 years of relevant working experience within the biopharmaceutical industry.

Required Qualifications:

  • 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 QC Labs.  Good interpersonal and influencing skills are important for a candidate’s success in this role.
  • In-depth knowledge of the principle discipline - validation and biopharmaceutical industry compliance, i.e. cGxPs, current industry standards and practices.

Additional Preferred Qualifications:

  • Working knowledge and hands-on experience with computer and application skills, scientific writing, supervision / management of teams and people (and their development), effective oral and written communication skills, and innovative thinking.
  • Ability to anticipate evolutions due to internal and external factors.
  • Ability to challenge status quo.
  • Conflict resolution and problem solving.
  • Familiarity with strategic planning, balanced judgment and risk analysis.
  • Planning and organizational skills.

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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