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Sanofi Group Director, Computer System Validation in Framingham, Massachusetts

Who You are:

As the Director, Computer System Validation you are responsible for managing the computerized system validation and compliance group and supporting the lifecycle of existing and new computerized systems and digital technologies. You are responsible for providing technical guidance related to Sanofi computer system directives aligned to cGxP regulations such as Part 11, ANNEX 11, etc. This position will develop validation procedures, templates, project plans, develop/update computerized system lifecycle program, and deliver large scale computerized system validation projects. Additionally, this position will also develop & deploy risk-based validation processes.

The Team:

The Digital Operations Technology Group is responsible for design, implementation, validation, support, and maintenance of Technology solutions in support of site goals and objectives; specifically, this group focuses on manufacturing systems & solutions including MES, DCS, PLC & related systems. The Digital Operations Technology Group is responsible for maintaining a stable, qualified, validated, and highly available computing infrastructure; additionally, we are also responsible for ensuring data integrity for our computerized systems & processes. This encompasses work processes that originate with the identification of a new or revised system, the design, installation, verification and validation of the system, the maintenance of the system in its commissioned/qualified/validated state and the retirement of the system at the end of its life. Additionally, through daily tasks, Digital Operations Technology supports current project operations and ensures compliance with regulatory, corporate and site requirements.

Job Highlights:

Management:

*Providing leadership and direction to support teams while embodying the principles of the Sanofi Global Leadership Model

*Managing and developing the performance of direct reports by setting clear “SMART” goals, providing timely performance feedback, recognizing and rewarding high achievers, and holding reports accountable for underperformance

*Ensuring timely issue escalation to senior management and cross-functional support teams

*Partnering with support teams i.e., Manufacturing, Quality, etc to ensure adherence to production schedules, while holding direct reports and teams responsible for compliance to all safety and quality regulations.

*Build and maintain a highly collaborative relationship with the Quality team and, specifically, with the QA Digital Director, and ensure that CSV processes are fully aligned with Quality standards and procedures

Computerized System Validation:

*Provide solutions to a wide range of difficult problems through individual efforts as well as strategic leveraging of outsourced personnel. Solutions are imaginative, thorough, practical, and consistent with organization objectives and applicable regulations

*Manage the CSV program to ensure that a consistent computerized system validation approach for IT infrastructure, Computerized Process Equipment, Manufacturing Computerized Systems, and Labs is used across Projects

*Develop/update validation project plans and computerized system lifecycle program documents to deliver large scale computerized system validation projects

*Manage computer system inventories, perform GxP criticality assessments, and Electronic Records Electronic Signature assessments

*Apply a risk-based approach to computerized system validation

*Support internal and external audits

*Ensure computerized systems meet applicable Data Integrity standards

Training /Deviations /Compliance:

*Complying with Sanofi requirements for training and Designing Department Training Plan and managing execution

*Utilizing quality systems to measure, analyze, and improve team performance

*Overseeing completion of investigations and deviations and ensuring all deviations and CAPA’s are closed in a timely manner

*Ensuring that MES, Automation, ERP, and other digital technology documentation is compliant, ensuring Inspection Readiness of assigned areas and participating in inspections conducted by external regulators

*Complying with requirements from Genzyme’s Safety Program including Health and Safety regulations and OSHA requirements

Continuous Improvement:

*Working collaboratively with inter-department and cross-functional teams to lead necessary changes in a timely and productive manner

*Partnering with Manufacturing and Quality to troubleshoot and drive resolution of process issues and proactively driving projects to improve manufacturing process

*Partnering with Operational Excellence to drive process improvements through Kaizens, Kanban, 5S and VSM

BASIC QUALIFICATIONS:

*Bachelor’s degree in Engineering, Science or related technological field w/ 10+ years of relevant work experience in a highly regulated industry ( Pharmaceutical, Biotechnology, Medical Device, Chemical, Aerospace, food, Semiconductor and Automotive )

*8+ years of experience developing and executing CSV project plans and protocols, and deploying large scale computerized system validation projects in a manufacturing environment

*5+ years of experience with developing & implementing risk-based computerized system validation programs

*5+ years of demonstrated hands-on CSV Leadership and Management experience including managing mixed teams of full time and contracted resources

*5+ years of hands-on experience with validation of Manufacturing Solutions including MES (Werum preferred), DCS (Delta V preferred), PLC & Data historian systems

*3+ years of experience with ensuring Data Integrity for cGMP computerized systems

*7+ years of experience with interpreting cGMP regulations for computerized systems (including 21 CFR Part 11, Annex 11)

PREFERRED QUALIFICATIONS:

*Automation engineering experience would be a plus

*Experience at a Director or Associate Director level would be a plus

Special Working Conditions:

*Occasional manufacturing operations support on an “on call” 24/7 basis

*Requires working in an industrial manufacturing environment including gowning

*Ability to work remotely 2 days a week

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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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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