The Senior Manager, Global Procurement – Supplier Quality Compliance will be responsible for leading a small team of Global Procurement Compliance professionals that support and maintain all cGMP compliance aspects of procurement operations. 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, and the management of the development of a Supplier Corrective Action Report (SCAR) management process via the compliance function.
A typical day may include:
* Tracks progress on all Global Procurement quality system deliverables, including deviation investigations, CAPAs and change controls, 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.
* Monitors, reports, and responds to Key Performance Indicators (KPIs) for the compliance functions, e.g. right-first-time (RFT) for deviation investigations.
* Performs deviation investigations and coordinates CAPA implementation as needed for high-risk events.
* Proactively manages and 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 Global Procurement compliance functions at other IOPS sites, including travel as needed.
* Oversees/directs the maintenance of the Approved Supplier List (ASL) and associated Periodic Review of suppliers.
* Leads the Supplier Review Board meeting and ensures all actions/decisions are documented and tracked appropriately.
* Supplier Audit Compliance – Drives 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.
* Leads the coordination and support of Procurement and Quality auditing needs for acceptable closure of Internal Regeneron and Supplier audit findings and to secure evidence that substantiates commitments. Tracks and reports CAPA in support of audit closure.
* May either directly or through a matrix structure, manage a team of professional level employees responsible for performing supplier quality management tasks (if applicable).
* May provide coaching and guidance on job performance and career development to direct reports (if applicable) and provides leadership examples for the organization.
This role may be right for you if you:
* Lead continuous improvement initiatives and build influential relationships with stakeholders and suppliers to drive results for Regeneron.
* Are an individual who is experienced operating with integrity, focus, and clarity in an environment of ambiguity to drive change and improvement.
* Have experience leading and guiding associate level professionals in a multi-national firm including writing performance reviews, setting annual objectives, coaching, and developing direct reports is preferred.
* Have 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.
* Have the ability to leverage standard business applications for communicating, presenting and analyzing (Word, Excel, PowerPoint).
To be considered for this role you must possess a Bachelor's degree plus 5 -7 years of relevant, progressive experience in procurement, quality or compliance including experience in Pharma/BioPharma / cGMP working environment. Must have managerial/supervisory experience leading collaborative teams in a global, matrixed organization.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way!
#J-18808-Ljbffr