Sr Manager Global Procurement

Regeneron Pharmaceuticals
1dOnsite

About The Position

We are currently looking to fill a Sr Manager Global Procurement. In this role you will be responsible for overseeing a team that supports and maintains all cGMP compliance aspects of procurement operations. Some of the major activities include but are not limited to the following: management and facilitation of the Approved Supplier List (ASL), deviation investigations, CAPAs, supplier audit closures and evidence follow up, support of regulatory inspections, SOP writing and revision, change controls, and the management of the development of a Supplier Corrective Action Report (SCAR) management process via the compliance function. Additional responsibilities include other compliance tasks and functions as assigned. In this role, a typical day may include the following: Ensures that the team operates as a global cohesive unit taking advantage of the efficiencies and ensuring compliance for all IOPS sites. Tracks progress on all Strategic Sourcing & Procurement quality system deliverables, including deviation investigations, CAPAs and change controls, ensuring quality and accuracy of documentation as well as adherence to established due dates. Interfaces regularly with Quality Assurance and other functional areas to remove obstacles, resolve conflicts, and to help facilitate critical decisions pertaining to quality system deliverables. Monitors, reports, and responds to Key Performance Indicators (KPIs) for the compliance functions, e.g. right-first-time (RFT) for deviation investigations. Performs deviation investigations and coordinates CAPA implementation as needed for high risk events. Proactively manages and maintains all Procurement cGMP procedures, documentation and training related to SOPs and Work Instructions. Continually reassess’ Strategic Sourcing & Procurement systems and processes for adherence to cGMPs and industry best practices and implements changes/improvements as needed. Represents the Strategic Sourcing & Procurement department on various topics during regulatory inspections, and coordinates responses to inspection observations as applicable. Supports the start-up/integration of Strategic Sourcing & Procurement compliance functions at other IOPS sites, including travel as needed.

Requirements

  • Bachelor’s degree
  • 8+ years of relevant experience, with at least 5 years of relevant experience in a cGMP environment or equivalent combination of education and experience

Responsibilities

  • Overseeing a team that supports and maintains all cGMP compliance aspects of procurement operations
  • Management and facilitation of the Approved Supplier List (ASL)
  • Deviation investigations
  • CAPAs
  • Supplier audit closures and evidence follow up
  • Support of regulatory inspections
  • SOP writing and revision
  • Change controls
  • Management of the development of a Supplier Corrective Action Report (SCAR) management process via the compliance function
  • Ensuring the team operates as a global cohesive unit taking advantage of the efficiencies and ensuring compliance for all IOPS sites
  • Tracking progress on all Strategic Sourcing & Procurement quality system deliverables, including deviation investigations, CAPAs and change controls, ensuring quality and accuracy of documentation as well as adherence to established due dates
  • Interfacing regularly with Quality Assurance and other functional areas to remove obstacles, resolve conflicts, and to help facilitate critical decisions pertaining to quality system deliverables
  • Monitoring, reporting, and responding to Key Performance Indicators (KPIs) for the compliance functions, e.g. right-first-time (RFT) for deviation investigations
  • Performing deviation investigations and coordinates CAPA implementation as needed for high risk events
  • Proactively managing and maintaining all Procurement cGMP procedures, documentation and training related to SOPs and Work Instructions
  • Continually reassessing’ Strategic Sourcing & Procurement systems and processes for adherence to cGMPs and industry best practices and implements changes/improvements as needed
  • Representing the Strategic Sourcing & Procurement department on various topics during regulatory inspections, and coordinates responses to inspection observations as applicable
  • Supporting the start-up/integration of Strategic Sourcing & Procurement compliance functions at other IOPS sites, including travel as needed

Benefits

  • health and wellness programs (including medical, dental, vision, life, and disability insurance)
  • fitness centers
  • 401(k) company match
  • family support benefits
  • equity awards
  • annual bonuses
  • paid time off
  • paid leaves (e.g., military and parental leave)
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