Position title: Manager Computer Systems Validation
Department: Qualification and Validation
Location: Toronto, ON
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.
Main 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.
Key Involvement in Decision-Making Process:- 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.
Local specificities:- 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.
About You Education:- 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.
This position is for a new vacant role that is now open for applications. AI Usage "Artificial Intelligence" refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company's Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regarding your personal information. You can also contact Canada's Privacy Officer via Sanofi's data subject request portal, Data Subject Rights Webform. The Data Subject Rights Webform can also be used to request access or correction of your personal information and file a complaint.
North America Applicants Only
The salary range for this position is:
102,600.00 - 152,600.00 (Includes target bonus)
Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefits programs, and additional benefits information can be found through the (CA)LINKOR (US) LINK.
La fourchette salariale pour ce poste est la suivante:
102,600.00 - 152,600.00 (Comprend le bonus cible)
La rémunération finale sera déterminée en fonction de l'expérience démontrée, des compétences, du lieu de travail et d'autres facteurs pertinents. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise, et des informations supplémentaires sur les avantages sociaux peuvent être trouvées via le lien
