Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: Responsible for overseeing a team of Strategic Sourcing & Procurement Compliance Specialists 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 development of a Supplier Corrective Action Report (SCAR) management process via the compliance function. Other compliance tasks/functions as assigned.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Manages and develops the Global IOPS Strategic Sourcing & Procurement compliance employees.
• Ensures that the team of compliance employees operate 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 in order 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.
• Reviews departmental trend reports to ensure 100 % Compliance
• Proactively manages and maintains all Procurement cGMP procedures, documentation and training related to SOPs and Work Instructions.
• Continually reassesses 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.
• Manages the maintenance of the Approved Supplier List (ASL) and associated Periodic Review of suppliers.
• 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.
• Manages 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.
• Develops a process to pull the management of Supplier Corrective Action Reports (SCARs) into the Compliance Team.
• Works closely with Legal, QA and Suppliers to help facilitate the execution and management of Master Services Agreements, Quality Agreements, etc. as required.
• Actions the Procurement responses to compliance related requests for data from Regulatory, Quality Assurance, Audit staff and other stakeholders
Knowledge and Skills:
• Excellent collaboration skills and the ability to work cross functionally across categories and internal stakeholders.
• Strong attention to detail is required.
• Microsoft Office required including strong Power Point and Excel skills.
• Acts with integrity in every aspect of the work and in line with Regeneron values.
• Makes decisions that put scientific and professional integrity and patient safety first.
• Makes good decisions based upon a mixture of analysis, knowledge, experience and judgment.
• Translates business objectives into actionable priorities.
Education and Experience:
• BA/BS required.
• Minimum 7 years of relevant experience with at least 4 years of relevant experience in a cGMP environment.
• In depth understanding of cGMP systems and processes with a particular emphasis on compliance required.
• Requires prior experience managing or leading teams.
• Familiarity and experience working in an ERP system is preferred.
* Title level will be determined based on skills and experience relevant to the role.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.