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Computer System Validation & Compliance Manager

Framingham, Massachusetts

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Responsibilities

The Information Technology & Solutions (ITS) Group is responsible for design, implementation, support, and maintenance of Information Technology solutions in support of site goals and objectives.  In such, ITS Group is responsible for maintaining a stable, Qualified, and highly available computing infrastructure. ITS Group is also responsible for implementing and Validating computer systems.  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, ITS supports current project operations and ensures compliance with regulatory, corporate and site requirements.

Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

This position is responsible for managing a computerized system compliance group and supportingthe lifecycle of existing or new computerized systems. The person will be 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 project plans, develop/update computerized system lifecycle program, and deliver large scale computerized system validation projects

Additional Responsibilities include:

  • 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.  Ensuring that appropriate levels of trained resources are available to meet production schedules.  
    • Working with recruiters to maintain staffing levels and meet approved hiring plans, conducting performance appraisals and career development assessments for all direct reports
    • Mentor compliance specialists to ensure that the team applies compliant, efficient solutions to projects.
  • 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.
    • Ensuring that a consistent computerized system validation approach for IT infrastructure, Computerized Process Equipment, Manufacturing Computerized Systems, and Labs is used across Projects at the Boston Hub.
    • 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 ERES assessments
    • Apply a risk-based approach to computerized system validation
    • Maintain validated state of computerized systems
  • Training /Deviations /Compliance: 
    • Complying with Sanofi requirements for training, maintaining training at or above 95% on time
    • Utilizing quality systems to measure, analyze, and improve team performance 
    • Leads staff meetings, providing updates of department activities and project statuses. 
  • Partnering with direct and indirect management chain to ensure the following:
    • Designing Department Training Plan and managing execution.
    • Ensuring Inspection Readiness of assigned areas 
    • Overseeing completion of investigations and deviations.
  • Partnering with QA to ensure the following:
    • Ensuring all deviations and CAPA’s are closed in a timely manner
    • Providing over sight for deviations and department documentation changes.
    • Ensuring that Process, Equipment and Automation documentation is compliant and inspection ready.
    • 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 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.

  • Leading People 
    • Sanofi’s leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers
  • Leading the Business
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  • Delivering to Customers
    • Sanofi’s leaders understand patient and customer needs and build relationships as required to meet manufacturing goals.  They create a vision for the organization while continuously improving operations by holding teams accountable to high standards of performance.

Basic Qualifications:

  • Bachelor’s degree in Engineering, Science or related technological field w/ 7+ years of relevant work experience
  • Master’s with 5+ years of relevant work experience
  • Experience with at least one of the following: Rockwell, MES, Siemens and Emerson DeltaV systems.
  • Direct experience with regulated environments (i.e. cGMP, OSHA, EPA).  
  • Experience with computerized system validation
  • Demonstrated knowledge of validation requirements for control systems in CGMP and/or ASTM environments.

Preferred Qualifications:  

  • Demonstrated management/leadership ability
  • Experience managing mixed teams of full time and contracted resources
  • Experience writing validation project plans, developing computerized system lifecycle program, and deploying large scale computerized system validation projects
  • Experienced in establishment of safe practices in a CGMP environment.
  • Proficient working with computer programs/applications such as Windows, VBA, MS Word, Excel, Access, etc.

Special working conditions:

  • Occasional manufacturing operations support on an “on call” 24/7 basis
  • Requires working in an industrial manufacturing environment including gowning.

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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