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.

This role may be for you if: You can maximize external data sources, market information, and collaborator engagement, and Regulatory Agencies to constantly improve Regeneron’s knowledge of the Compliance Landscape.

You operate with integrity, focus, and transparency in an environment of ambiguity to drive change and improvement.

You possess a proven record of leading continuous improvement initiatives and building influential collaborations and supplier relationships to get results for Regeneron.

You can drive Key Performance Indicators for the compliance functions, e.g. right-first-time for deviation investigations.

Solid understanding 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 use standard business applications for communicating, presenting and analyzing (Word, Excel, Powerpoint).

To be considered for this position you must have a bachelor's degree in a relevant field of study plus 12+ years of progressive experience in procurement, Quality and/or Compliance preferably including significant experience in Pharma/BioPharma. Experience leading manager level professionals in a multi-national firm including writing performance reviews, setting annual objectives, coaching, and developing team members.