Commissioning and Qualification Manager

Role Summary

Location: Framingham, MA. 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.

Responsibilities

• Lead the Process, Plant & CQ team and ensure sufficient resources available for all process, plant & CQ activities based on site needs and strategic workforce planning
• Leads investigations & develops CAPAs for unplanned disruptions, breakdowns and deviations
• Identify improvement opportunities for critical systems
• Act as an SME for an quality related discussions during audits/inspections and provide support to Capital Projects as required
• Implementing process improvements to enhance efficiency, safety, and quality.
• Participate in applicable COPs

Qualifications

• BS - Engineering, Life Sciences or related discipline - preferred. A combination of education and experience will be considered.
• 5+ years of experience in GMP regulated environments.
• Extensive knowledge of regulatory requirements for CQ activities and be able to defend and justify CQ plans and practices during internal/external audits.
• Strong People Management skills and demonstrated ability to work with cross functional teams
• Technical writing and investigation techniques

Education

• As listed under Education & Experience: BS in Engineering, Life Sciences or related discipline (preferred).