Manager Computer Systems Validation

Sanofi•Toronto, ON

12h•CA$102,600 - CA$152,600•Onsite

About The Position

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. The Computerized System Validation (CSV) Group: Responsible for validation of computerized systems crossing site functional areas of M&S, including site enterprise systems maintained by ITS, Manufacturing and Supply Chain systems, Site Quality Operation’s quality systems and site Engineering systems. The group, as a quality business owner for computerized system validation, is responsible and the owner of governance procedures for validation of computerized systems covering full system life cycle. Leading and maintaining computerized system/equipment inventory list. Performing gap assessments against global quality standard on CSV to ensure the alignments Leading and performing periodic review of validated GxP computerized systems to ensure that systems remain in compliance and have been maintained in a validated state. Supporting regulatory inspection and global quality audit on computerized systems. Leading and supporting decommission of systems, equipment and facilities on site. Responsible and performing quality oversight of the integrity of Quality Material Master Data. Maintaining GMP Master Data standards, policies and procedures to improve data quality and ensure compliance with regulatory requirements and company standards. Defining compliance requirements for new GMP Master Data sets (e.g., Bill of Materials, Recipes, Production Versions) and reviewing, assessing, and approving changes to GMP Master Data that governs GMP processes.

Requirements

Bachelor’s degree with 10 years of experience.
Degree in computer technology, science, or regulatory discipline is preferred, including 2-5 years experience for computerized systems validation and Quality practices, and 6-8 years experience on leading computerized systems validation responsibilities and Quality practices.
Masters Degree in science/engineering or a related field is preferred, with 5 - 7 years of experience in a biopharmaceutical environment and In-depth knowledge of the biologic products, and the associated regulatory requirements is mandatory.

Responsibilities

Implementing and maintaining qualification and validation strategies, plans, protocols, and reports, in collaboration with internal and external stakeholders.
Maintaining and updating the governance procedures, and ensuring alignment with the company's quality management system .
Ensuring the compliance of qualification and validation with applicable regulatory requirements and company quality standards .
Maintaining a system to ensure compliance and quality risks are properly identified, tracked, and mitigated.
Ensuring the proper documentation, review, and approval of qualification and validation deliverables, such as risk assessments, traceability matrices, test scripts, deviations, and summary reports.
Ensuring that all equipment and systems are properly qualified and validated.
Overseeing the execution of qualification and validation studies.
Establishing metrics and monitoring data for the qualification and validation activities, to identify trends and issues and to conduct periodic reviews and re-validation as necessary.
Establishing and monitoring key performance indicators (KPIs) and metrics for the qualification and validation, and report on the qualification and validation performance and effectiveness.
Promoting a culture of quality throughout the organizations (e.g., engineering, MSAT, operations) involved in qualification and validation activities.
Identifying and driving continuous improvement initiatives and projects to enhance the qualification and validation efficiency and effectiveness fostering a culture of continuous improvement.
Evaluating and recommending new technologies, tools, and methods to enhance qualification and validation processes and outcomes.
Performing reviews to assess the effectiveness of the qualification and validation activities.
Leading and managing the qualification and validation team, including hiring, training, coaching, professional development, and performance evaluation.
Quality qualification and validation representative in Q&V projects for new and existing equipment and facilities within the defined scope.
Participating in regulatory inspections and audits, providing quality validation support, and support site experts (i.e., users, MSAT, or Engineering).
Participating in the validation CoP led by global and, if requested, participating in the CoE and ensuring local communication.
Prioritize and allocate qualification and validation projects, resources, and budget.
Endorse qualification and validation strategies using a TRT approach.
Support and contribute updates of the site Validation Master Plan (sVMP).
Support and coordinate with other departments to ensure smooth validation processes.
Prepare internal and external audits and HA inspections related to validation and qualification by identifying Q&V risks (A) and proposing mitigation plan.
Providing guidance as Quality Operations on project team(s) for quality events remediation activities related to qualification and validation activities in collaboration with the cross-functional teams.
Assuring compliance with meeting GxP requirements through validation activities for Computerized Equipment and/or Systems.
Ensuring compliance with Global and Regulatory requirements related Validation through GAP Assessment and Corrective actions.
Taking a proactive approach for aligning validation quality system through monitoring and incorporating changes with new regulations and global guidance.
Where required, participating in local and global Quality initiatives impacting quality systems to ensure harmonization of processes and initiatives including those focusing on improving Quality Support.
Building and maintaining networks within Sanofi and, as required, participates in on- going global quality initiatives via Community of Practice (CoP) and Subject matter expert (SME) networks.
Working within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.