Director, Global Procurement Compliance

Regeneron Pharmaceuticals
259d$169,600 - $282,600

About The Position

The Director, Global Procurement Compliance will be responsible for directing a team of Compliance Managers and Specialists that support and maintain all cGMP compliance aspects of procurement operations. In addition to leading the Compliance team this individual will be a member of the Global Procurement Direct Category Leadership team and will provide input and be accountable for the overall efficiency of the team. 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, Supplier Periodic Reviews, and the management of Supplier Corrective Action Report (SCAR) via the compliance function. In this role a typical day may include: Accountable for leading, defining, and implementing strategy to serve global and regional business needs. Works closely with team members to lead discussions and aligns priorities with Procurement management and partners. Represents Global Procurement by participating in interpersonal decisions in the cGMP landscape with critical short and long-term impact on the success, efficiency, growth, and results of the organization and company. Works with Category Leaders to ensure compliance with appropriate GxPs and other applicable regulations. May either directly or through a matrix structure, lead a team of professional level employees responsible for performing tasks Provides mentorship to the Procurement Compliance team around job performance and career development and provides leadership examples for the organization. Uses data to drive decision-making for successful projects. Coordinate progress on all Global Procurement quality system results, 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 issues, and to facilitate critical decisions pertaining to quality system objectives. Performs deviation investigations and coordinates CAPA implementation as needed for high-risk events. Proactively maintains 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 implements changes/improvements as needed. Supports the start-up/integration of compliance functions at other sites, including travel as needed. Maintenance of the ASL and associated Periodic Review of suppliers. Provides leadership of the Supplier Review Board meetings and ensure all actions / decisions are detailed appropriately Supplier Audit Compliance - Drives successful audit closures by focusing on proactive issue resolutions and communication with suppliers.

Requirements

  • Bachelor's degree in a relevant field of study.
  • 12+ years of progressive experience in procurement, Quality and/or Compliance, preferably in Pharma/BioPharma.
  • Experience leading manager level professionals in a multi-national firm.
  • Solid understanding of and experience in setting up and maintaining a Quality Management System (QMS).
  • Ability to use standard business applications for communicating, presenting, and analyzing (Word, Excel, PowerPoint).

Nice To Haves

  • Proven record of leading continuous improvement initiatives.
  • Experience building influential collaborations and supplier relationships.
  • Ability to drive Key Performance Indicators for compliance functions.

Responsibilities

  • Direct a team of Compliance Managers and Specialists for cGMP compliance in procurement operations.
  • Manage and facilitate the Approved Supplier List (ASL).
  • Conduct deviation investigations and coordinate CAPA implementation.
  • Support regulatory inspections and manage supplier audit closures.
  • Write and revise Standard Operating Procedures (SOPs).
  • Lead discussions and align priorities with Procurement management.
  • Mentor the Procurement Compliance team on job performance and career development.
  • Use data to drive decision-making for successful projects.
  • Ensure quality and accuracy of documentation in Global Procurement quality systems.
  • Interface with Quality Assurance and other functional areas to resolve issues.
  • Proactively maintain Procurement cGMP procedures and documentation.
  • Support the start-up/integration of compliance functions at other sites.
  • Lead Supplier Review Board meetings and ensure proper documentation of actions.

Benefits

  • Health and wellness programs.
  • Fitness centers.
  • Equity awards.
  • Annual bonuses.
  • Paid time off for eligible employees.

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What This Job Offers

Job Type

Full-time

Career Level

Senior

Industry

Professional, Scientific, and Technical Services

Education Level

Bachelor's degree

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