The Director, Global Procurement Compliance will be responsible for leading a team of Compliance Managers and Specialists that support and maintain all cGMP compliance aspects of procurement operations. In addition to leading the Compliance team this individual will be a member of the Global Procurement Direct Category Leadership team. As a member of the leadership team, he/she will provide input and be accountable for the overall effectiveness of the team.
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, Supplier Periodic Reviews, and the management of Supplier Corrective Action Report (SCAR) via the compliance function.
This role can be based at either one of our 2 Corporate Manufacturing & Supply locations in the Capital Region, NY or Limerick Ireland - this role is not open to fully remote work arrangements.
A typical day may include:
- Accountable for leading, defining, and implementing the global Procurement Compliance strategy to serve global and regional business needs.
- Works closely with stakeholders to lead discussions related to the Procurement Compliance and aligns priorities with Procurement management and stakeholders.
- Represents Global Procurement by participating in organizational decisions in the cGMP landscape with critical short and long-term impact on the success, efficiency, growth, and results of the organization and company.
- Works closely with Category Leaders to ensure compliance with appropriate GxPs and other applicable regulations.
- May either directly or through a matrix structure, manage a team of professional level employees responsible for performing cGMP Compliance related tasks (if applicable.)
- Provides coaching and guidance to the Procurement Compliance team around job performance and career development and provides leadership examples for the organization.
- Uses data to drive decision-making for successful cGMP Compliance related projects.
- 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.
- 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 and /or delegate the leadership of the Supplier Review Board meetings 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.
This role may be for you if...
- You can leverage external data sources, market information, and stakeholder engagement, and Regulatory Agencies to constantly improve Regeneron’s knowledge of the Compliance Landscape.
- You operate with integrity, focus, and clarity in an environment of ambiguity to drive change and improvement.
- You possess a proven track record of leading continuous improvement initiatives and building influential relationships with stakeholders and suppliers to drive results for Regeneron.
- You can drive Key Performance Indicators (KPIs) for the compliance functions, e.g. right-first-time (RFT) for deviation investigations.
- 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.
- Ability to leverage standard business applications for communicating, presenting and analyzing (Word, Excel, Powerpoint)
To be considered for this position you must have a bachelor's degree in a relevant field of study plus 12+ years of progressive experience in procurement, Quality and/or Compliance preferably including substantial experience in Pharma/BioPharma. Experience leading manager level professionals in a multi-national firm including writing performance reviews, setting annual objectives, coaching, and developing direct reports.
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.S.-based 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)
$169,600.00 - $282,600.00
What We Do
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
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