Sr Manager Supplier Quality and Compliance

We are currently looking to fill a Sr Manager Supplier Quality and Compliance. In this role you will be responsible for overseeing a team that supports and maintains all cGMP compliance aspects of procurement operations.  Some of 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. Additional responsibilities include other compliance tasks and functions as assigned.

In this role, a typical day may include the following:

• Ensures that the team operates as a global cohesive unit taking advantage of the efficiencies and ensuring compliance for all IOPS sites.

• Tracks progress on all Strategic Sourcing & 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 conflicts, and to help facilitate critical decisions pertaining to quality system deliverables.

• 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’ Strategic Sourcing & Procurement systems and processes for adherence to cGMPs and industry best practices and implements changes/improvements as needed. 

• Represents the Strategic Sourcing & Procurement department on various topics during regulatory inspections, and coordinates responses to inspection observations as applicable.

• Supports the start-up/integration of Strategic Sourcing & Procurement compliance functions at other IOPS sites, including travel as needed.

This role may be a fit for you if you:

• Can oversee and direct the maintenance of the Approved Supplier List (ASL) and associated Periodic Review of suppliers.

• Drive 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.

• Can lead the coordination with Cross Functional Compliance resources to support 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.

• Have the ability to work closely with Legal, QA and suppliers to help facilitate the execution and management of Master Services Agreements, Quality Agreements, etc. as required.

• Can action on the procurement responses to compliance related requests for data from Regulatory, Quality Assurance, Audit staff and other stakeholders.

To be considered for this role you must hold a Bachelor’s degree and the following amount of relevant experience:

• Sr Manager level:  8+ years of relevant experience, with at least 5 years of relevant experience in a cGMP environment or equivalent combination of education and experience.

$126,300.00 - $206,100.00