Manager Validation Systems

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City : Toronto

Category : Quality, R&D

Industry : Pharmaceutical

Employer : Sanofi

Manager Validation System

Reference #: R2511228

Department: Quality Operations Validation Systems

Location: Toronto, Ontario

Position Summary:

This role is responsible for GxP computerized systems periodic review and the electronic data periodic review (EDPR) programs. The candidate will be responsible for managing and leading GxP computerized system periodic review program to ensure that validated GxP computerized systems are maintained in a validated and controlled state, and remain in compliance with GxP regulatory requirements¸ meeting company policies and procedures, and fitting for intended use. The candidate is also responsible for managing and leading EDPR program to ensure that GxP electronic data, such as master data, raw / intermediate data, and final results, is controlled under relevant governance procedures.

Major Responsibilities:

  • Manage and lead GxP computerized systems periodic review program by:
    • Establishing site system periodic review plan with periodic review schedule by following the relevant governance SOPs on system periodic review. The plan will cover GxP computerized systems utilized for manufacturing shop floors, QC Laboratories, and systems supported and maintained by Information Technology & Solutions.
    • Communicate and coordinate with system and process owners, system supporting functions to ensure that system periodic review plan is reviewed, approved and ready for execution.
    • Coordinate the execution of the periodic review plan to ensure that the periodic review schedule is completed as expected;
    • Develop the periodic review report to provide evidence that an effective review has taken place, with necessary corrective actions and plans in place as needed.
    • Coordinate and follow up on closure of corrective actions and plans as needed.

  • Manage and lead electronic data periodic review (EDPR) program by:
    • Developing annual site electronic data periodic review plan with review schedule per relevant governance procedures;
    • Communicate and coordinate with system and process owners to ensure that the EDPR plan is reviewed, approved and ready for execution.
    • Coordinate the execution of the EDPR plan to ensure that the review schedule is completed as expected.
    • Support in determining corrective actions resulted from EDPR process. Follow-up.
    • Develop the EDPR report to provide evidence that an effective review has taken place, with necessary corrective actions and plans as needed.
    • Coordinate and follow up on closure of corrective actions and plans as needed.

  • Update and maintain site computerized system inventory list and ensure it is current, accurate and complete to reflect the system status.
  • Participate and provide audit and inspection support and coordination for system validation related requests.

Education & Experience:

  • A degree in Engineering or 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 with cross functional project teams which include members from various organizations within Sanofi Pasteur, such as Bulk-manufacturing, Manufacturing Technology, Engineering, QC Labs and Information Technology & Solutions. 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

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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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