Procurement Compliance Director

4 weeks ago

Albany, New York, United States Regeneron Pharmaceuticals Full time
Job Description

Regeneron Pharmaceuticals is seeking a highly skilled and experienced professional to fill the role of Associate Director, Procurement Compliance. This position will play a critical role in enabling the company's scientific advancements and building a procurement capability that acts as a competitive advantage.

Key Responsibilities:

  • Lead a team of Global Procurement Compliance Managers and Specialists to support and maintain all cGMP compliance aspects of procurement operations.
  • Manage and facilitate the Approved Supplier List (ASL), deviation investigations, CAPAs, supplier audit closures, and evidence follow-up.
  • Support regulatory inspections, SOP writing and revision, change controls, and the management of the development of a Supplier Corrective Action Report (SCAR) management process.
  • Track progress on Global Procurement quality system deliverables, including deviation investigations, CAPAs, and change controls.
  • Interface with Quality Assurance and other functional areas to remove obstacles, resolve issues, and facilitate critical decisions.
  • Monitor, report, and respond to Key Performance Indicators (KPIs) for the compliance functions.
  • 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.
  • Support the start-up/integration of Global Procurement compliance functions at other IOPS sites.
  • 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.

Requirements:

  • Bachelor's degree in a relevant field of study plus 10+ years of relevant, progressive experience in procurement, including experience in Pharma/BioPharma/cGMP working environments.
  • 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 that 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 Pharmaceuticals:

Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, Regeneron's unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development.

Regeneron's medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases, and rare diseases. Headquartered in Tarrytown, NY, Regeneron has 13,300 employees.

Our commitment to patients extends well beyond our labs. 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.

Regeneron's 2023 revenues were greater than $13 Billion. Key products of Eylea, Dupixent, and Libtayo are all blockbuster products with Eylea and Dupixent in the top 10 pharmaceuticals on market by revenue.

Notably, all 12 products marketed by Regeneron were discovered and developed internally. Despite being a large cap biopharma company, Regeneron anticipates significant growth over the coming years primarily due to growth of on-market products and returns from significant R&D investment.

Regeneron plans $4.4B in R&D investment this year with 35 products in clinical development with a pipeline focused on Ophthalmology, Immunology, and Oncology therapeutic areas.

The Global Procurement team is investing in resources both to support the team growth and anticipated growth in spend. The vision is to build a procurement capability that acts as a competitive advantage to Regeneron and evolve the organizational structure to focus the team on end-to-end category accountability and invest in appropriate category leadership.

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