Procurement Compliance Director

3 days ago


Troy, Michigan, United States Regeneron Pharmaceuticals Full time
Job Summary

We are seeking an experienced Associate Director, Procurement Compliance to join our Global Procurement team at Regeneron Pharmaceuticals. This role will be responsible for leading a team of Global Procurement Compliance Managers and Specialists, ensuring compliance with cGMP regulations and maintaining the Approved Supplier List (ASL).

Key Responsibilities
  • Lead a team of Global Procurement Compliance Managers and Specialists to ensure compliance with cGMP regulations and maintain the ASL.
  • Develop and implement compliance procedures and processes to ensure adherence to regulatory requirements.
  • Collaborate with Quality Assurance and other functional areas to remove obstacles, resolve issues, and facilitate critical decisions pertaining to quality system objectives.
  • Monitor, report, and respond to Key Performance Indicators (KPIs) for the compliance functions, including right-first-time (RFT) for deviation investigations.
  • Perform deviation investigations and coordinate CAPA implementation as needed for high-risk events.
  • Proactively manage and maintain all Procurement cGMP procedures, documentation, and training related to SOPs and Work Instructions.
  • Continually reassess Global Procurement systems and processes for adherence to cGMPs and industry standard methodologies and implement changes/improvements as needed.
  • Support the start-up/integration of Global Procurement compliance functions at other IOPS sites, including travel as needed.
  • Oversee/direct the maintenance of the Approved Supplier List (ASL) and associated Periodic Review of suppliers.
  • Lead the Supplier Review Board meeting and ensure all actions/decisions are documented and tracked appropriately.
  • Drive successful audit closures by focusing on proactive issue resolutions and communication with suppliers to effect acceptable audit closures and gathering of evidence of closure for raw material and component suppliers.
Requirements
  • Bachelor's degree in a relevant field of study plus 10+ years (or Master's degree with 8+ years') of relevant, progressive experience in procurement, including experience in Pharma/BioPharma/cGMP working environment.
  • Experience leading and guiding associate-level professionals in a multi-national firm, including writing performance reviews, setting annual objectives, coaching, and developing direct reports.
  • Good working knowledge of and experience in setting up and maintaining a QMS which meets the legislative requirements of human medicines in the EU and USA.
  • Ability to leverage standard business applications for communicating, presenting, and analyzing (Word, Excel, PowerPoint).
About Regeneron

Regeneron Pharmaceuticals is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. We are proud to support the communities we serve, to embrace a culture and business model of patients over profits, and to hold the highest ethical standards when it comes to patient well-being.

Regeneron's ethos of Doing Well by Doing Good centers around three responsibility focus areas: 1) Improve the lives of people with serious disease, 2) Foster a culture of integrity and excellence, and 3) Build sustainable communities.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.



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