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 c GMP 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.
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.
Continually reassess Global Procurement systems and processes for adherence to c GMPs and industry standard methodologies and implements changes/improvements as needed.
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.
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, Power Point) 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/Bio Pharma / c GMP working environment.
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.
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.
Key products of Eylea, Dupixent, and Libtayo are all blockbuster products with Eylea and Dupixent in the top 10 pharmaceuticals on market by revenue.
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 $4.4 B in R&D investment this year with 35 products in clinical development with a pipeline focused on Ophthalmology, Immunology, and Oncology therapeutic areas.
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.
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 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.
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.