Job Description
Regeneron leads with science and our global procurement team will play a critical role in enabling our scientific advancements. Our vision is to build a procurement capability that acts as a competitive advantage to Regeneron. This is a great opportunity to join us and help to shape and drive the development of the new organization and realize our vision. The Associate Director, Procurement Compliance will be responsible for leading a team of Global Procurement Compliance Managers and 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 management of the development of a Supplier Corrective Action Report (SCAR) management process via the compliance function. The role requires 5 days onsite at Regeneron's IOPS facilities. This role is not open to hybrid or fully remote-based work arrangements 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. Lead the Supplier Review Board meeting and ensure 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 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. Manage team of professional level employees responsible for performing supplier quality management tasks (if applicable.) Provides coaching and guidance on job performance and career development to direct reports 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 in a relevant field of study plus 10+ years (or Masters degree with 8+ years') of relevant, progressive experience in procurement, including experience in Pharma/BioPharma / cGMP working environment. Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, Regeneron's unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in Regeneron's laboratories. Regeneron's medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases, and rare diseases. Headquartered in Tarrytown, NY, Regeneron has 13,300 employees. Our commitment to patients extends well beyond our labs. We are proud to support the communities we serve, to embrace a culture and business model of patients over profits and to hold the highest ethical standards when it comes to patient well-being. Regeneron's ethos of Doing Well by Doing Good centers around three responsibility focus areas: 1) Improve the lives of people with serious disease 2) Foster a culture of integrity and excellence and 3) Build sustainable communities. Regeneron's 2023 revenues were greater than $13 Billion. Key products of Eylea, Dupixent, and Libtayo are all blockbuster products with Eylea and Dupixent in the top 10 pharmaceuticals on market by revenue. Notably, all 12 products marketed by Regeneron were discovered and developed internally. Despite being a large cap biopharma company, Regeneron anticipates significant growth over the coming years primarily due to growth of on-market products and returns from significant R&D investment. Regeneron plans $4.4B in R&D investment this year with 35 products in clinical development with a pipeline focused on Ophthalmology, Immunology, and Oncology therapeutic areas. The Global Procurement team is investing in resources both to support the team growth and anticipated growth in spend. The vision is to build a procurement capability that acts as a competitive advantage to Regeneron and evolve the organizational structure to focus the team on end-to-end category accountability and invest in appropriate category leadership, including further development of our center of excellence and establishing an international markets procurement team. The global Procurement team will be structured with category teams having end to end accountability for category management, sourcing, contracting, and supplier relationship management for assigned categories. These category teams will be enabled by procurement colleagues in an expanded Center of Excellence, an International Markets team, and a Capability Center all accountable for driving consistency and efficiency. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) 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. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $142,700.00 - $232,900.00