Event Deviation Change Management Expert

Reference no. R2861488

Position title:

Event Deviation Change Management Expert Department:
Quality and Operations

Location:

Toronto, ON

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

Leadership role with indirect authority driving the investigation and CAPA commitments from Sanofi Canada internal and external partners to meet Health Canada requirements. High level of autonomy, authority and risk management as the owner of Event Deviations, CAPAs and Change Controls for Sanofi Canada for local activities as well as external activities for a substantial portfolio of imported products. This role leads these activities for all relevant Sanofi Business units performing GxP and health-regulated functions with a heavy focus on high risk GMP activities.

The role is required to analyze organizational needs, develop and support operational plans and best practices to ensure a streamlined and fully compliant operation for the Sanofi Canada licenses.

• Event/Deviation/CAPA Centralized process owner for Sanofi Canada aligned with Global requirements to document nonconformities, root cause and the implementation and tracking of appropriate corrective and preventative actions to drive product and process improvements, commensurate with the significance of the risk or deviation.
• Assesses criticality of deviations for Local, Regional and Global Quality escalation requirements and manages escalation process
• Presents and defends appropriateness of investigations, root cause determinations, corrective actions and product release decisions during audits and inspections
• Change Management Operations Oversight and management of planned temporary or permanent changes to Canada market product, processes, license activities to align with Health Canada expectations for Importers
• Ensuring formal documentation, approval and traceability, effected in a timely manner, with a high degree of assurance that potential downstream impacts are appropriately assessed and proactively acted on to minimize risk and support product/process robustness

• Drive the alignment with Global stakeholders, other teams and quality pillars as required
• Influence without authority and effectively advocate for Canadian market needs beyond Corporate Standard requirements
• Oversee the handling of QA documents based on established systems and processes. e.g. SOPs
• Assemble reports related to Change Controls, Events and CAPAs as required
• Serve in a backup capacity to Quality Lead and other Quality Specialists for their respective responsibilities as delegated
• Assist in the development and management of Training Program Metrics tracking for event deviation occurrence review and other related trending to reduce recurrences, improve performance and increase Quality standards
• Leads and participates in Continuous Improvement projects
• Works with internal and external stakeholders to provide Quality expertise related to Canadian market requirements
• Other duties as assigned

• Bachelor's Degree in Science or equivalent.
• 7-10 years of relevant experience in pharmaceutical industry (Preferably in QA, QC, Production or equivalent).
• Extensive knowledge of Canadian GMPs.
• Excellent analytical and problem-solving abilities
• Excellent ability to influence without authority and overcome challenges.
• Experience with Canadian importation is highly preferred.
• Ability to maintain good interpersonal relationships
• Ability to set priorities
• Good communication skills (verbal and written) English:
  Excellent knowledge (reading, writing and oral) French:
  Written and spoken…