Job Summary:
The Director, Global Procurement Compliance will lead a team of Compliance Managers and Specialists responsible for supporting and maintaining all cGMP compliance aspects of procurement operations. This individual will be a member of the Global Procurement Direct Category Leadership team, providing input and being accountable for the overall effectiveness of the team.
Major activities include but are not limited to 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.
This role may be based at one of our Corporate Manufacturing & Supply locations in the Capital Region, NY or Limerick Ireland. A typical day includes leading, defining, and implementing the global Procurement Compliance strategy to serve global and regional business needs.
The successful candidate will work closely with stakeholders to align priorities with Procurement management and represent Global Procurement by participating in organizational decisions in the cGMP landscape.
Key Responsibilities:
* Lead discussions related to Procurement Compliance and align priorities with Procurement management and stakeholders
* Represent Global Procurement in organizational decisions in the cGMP landscape
* Work closely with Category Leaders to ensure compliance with appropriate GxPs and other applicable regulations
* Manage a team of professional level employees responsible for performing cGMP Compliance related tasks
* Provide coaching and guidance to the Procurement Compliance team around job performance and career development
* Use data to drive decision-making for successful cGMP Compliance related projects
* Track progress on all Global Procurement quality system deliverables
* Interface regularly with Quality Assurance and other functional areas to remove obstacles and resolve issues
* Perform deviation investigations and coordinates CAPA implementation as needed for high-risk events
* Proactively manage and maintain all Procurement cGMP procedures, documentation and training
* 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)
* Lead and/or delegate the leadership of the Supplier Review Board meetings
* Ensure all actions/decisions are documented and tracked appropriately
Requirements:
* Bachelor's degree in a relevant field of study plus 12+ years of progressive experience in procurement, Quality and/or Compliance
* Substantial experience in Pharma/BioPharma
* Experience leading manager level professionals in a multi-national firm
* Ability to leverage external data sources, market information, and stakeholder engagement to improve Regeneron's knowledge of the Compliance Landscape
* Proven track record of leading continuous improvement initiatives and building influential relationships with stakeholders and suppliers
* 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:
We have an inclusive and diverse culture that provides comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Regeneron is 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.
The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.