Manager Computer Systems Validation
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Key skills for this role
About the Role
Sanofi seeks a Manager of Computer Systems Validation to lead validation of computerized systems in a biopharmaceutical manufacturing environment. The role involves ensuring compliance with GxP regulations, managing a team, and overseeing validation strategies.
Key Skills for This Role
Responsibilities
- Implement and maintain qualification and validation strategies, plans, protocols, and reports
- Maintain and update governance procedures and ensure alignment with quality management system
- Ensure compliance of qualification and validation with regulatory requirements and company quality standards
- Maintain system to ensure compliance and quality risks are properly identified, tracked, and mitigated
- Oversee execution of qualification and validation studies
- Establish metrics and monitor data for qualification and validation activities
- Establish and monitor KPIs for qualification and validation
- Promote a culture of quality throughout organizations involved in qualification and validation
- Identify and drive continuous improvement initiatives to enhance qualification and validation efficiency
- Evaluate and recommend new technologies, tools, and methods to enhance validation processes
- Lead and manage the qualification and validation team, including hiring, training, coaching, and performance evaluation
- Participate in regulatory inspections and audits, providing quality validation support
Requirements
- Bachelor's degree with 10 years of experience; degree in computer technology, science, or regulatory discipline preferred
- 2 5 years experience in computerized systems validation and Quality practices
- 6 8 years experience leading computerized systems validation responsibilities and Quality practices
- Masters Degree in science/engineering or related field preferred with 5 7 years in biopharmaceutical environment
- In depth knowledge of biologic products and associated regulatory requirements is mandatory
Full Job Posting
About the job
- The Computerized System Validation (CSV) Group is responsible for validation of computerized systems crossing site functional areas.
- The group is the quality business owner for computerized system validation and owns governance procedures.
- This position is for a new vacant role.
Main Responsibilities
- Implementing and maintaining qualification and validation strategies, plans, protocols, and reports.
- 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.
- 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.
- Establishing and monitoring key performance indicators (KPIs) and metrics for the qualification and validation.
- Promoting a culture of quality throughout the organizations involved in qualification and validation activities.
- Identifying and driving continuous improvement initiatives and projects.
- Evaluating and recommending new technologies, tools, and methods to enhance qualification and validation processes.
About You
- Bachelor’s degree with 10 years of experience. Degree in computer technology, science, or regulatory discipline is preferred.
- 2 5 years experience for computerized systems validation and Quality practices.
- 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.
- In depth knowledge of the biologic products, and the associated regulatory requirements is mandatory.
Why Choose Us?
- Bring the miracles of science to life alongside a supportive, future focused team.
- Discover endless opportunities to grow your talent and drive your career.
- Enjoy a thoughtful, well crafted rewards package that recognizes your contribution.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits.
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