Associate Compliance Specialist - Procurement

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 60,000 - 80,000; Full time

Job summary

A global biopharmaceutical company in Munster is seeking an Associate Compliance Specialist - Procurement. This role focuses on supporting cGMP compliance and managing supplier audits. Ideal candidates should have a Bachelor's degree and 2 years of experience in a cGMP environment, preferably in Pharma/BioPharma. Strong Microsoft Office skills, especially in PowerPoint and Excel, are essential. This position requires 5 days onsite with a focus on operational integrity and supplier relationship management.

Benefits

Health and wellness programs

401(k) company match

Equity awards

Paid time off

Paid leaves for eligible employees

Qualifications

• 2 years experience in cGMP environment in quality, compliance and/or procurement.
• Experience in Pharma/BioPharma preferred.
• Strong PowerPoint and Excel skills.

Responsibilities

• Support compliance initiatives in Global Procurement.
• Maintain Approved Supplier List documentation.
• Conduct Supplier Audit Compliance.
• Track and report CAPA to support audit closure.

Skills

Working knowledge with quality and compliance electronic tools/systems

Operational integrity and clarity in ambiguity

Continuous improvement mindset

Strong relationship building with stakeholders and suppliers

Experience with SCARs, ASLs, CAPAs

Education

Bachelor's degree in a relevant field

Tools

Microsoft Office

Job description

The Associate Compliance Specialist - Procurement will support the planning and execution of compliance initiatives utilizing the sourcing process for raw material manufacturers and distributors. Supports and maintains all cGMP compliance aspects of Global Procurement operations under the direction and guidance of Sourcing Management. Ensures organization and timely completion of Approved Supplier List documentation in addition to Process deviations assigned to Sourcing (CAPAs, NOEs, EOEs) and supports closure of QA Audits related to audits of raw material manufacturers and distributors.

*This role requires 5 days onsite and is not open to remote / hybrid work

In this role a day may include, but are not limited to, the following:

• Supports and proactively maintains all Sourcing cGMP procedures, documentation and training related to SOP and Work Instructions.
• Supports and maintains Approved Supplier List (ASL).
• Supports compliance needs and coordinates with other sites to ensure engagement, feedback and buy-in related to Global Procurement document revisions.
• Supplier Audit Compliance: Drives successful audit closures by focusing on proactive issue resolutions and communication with suppliers to effect acceptable audit closures for raw materials.
• Coordinates with Cross‑Functional Compliance resources to support Global Procurement and Quality Auditing needs for acceptable closure of audit findings and to secure evidence that substantiates supplier commitments.
• Tracks and reports CAPA to support audit closure.
• Executes cGMP compliance documents and supports cGMP activities among the Global Procurement team.
• Supports and assists with the management of Supplier Corrective Action Reports (SCARs)
• Completes Global Procurement change controls to ensure they are done correctly and effectively.
• Works with Global Procurement staff to review and drives timely closure of NOE / deviations and associated processes (CAPA).
• Actions the Global Procurement responses to compliance related requests for data from Regulatory, Quality Assurance, Audit staff and other stakeholders.
• Supports the Global Procurement staff as required for assigned categories and participates in other procurement office duties as assigned.

This role may be for you if you have:

• Working knowledge with quality and compliance electronic tools/ systems
• Individual who is experienced operating with integrity, focus, and clarity in an environment of ambiguity to drive change and improvement
• Continuous improvement mindset in identifying areas of improvements and working with leadership to implement them.
• Ability to build strong relationships with stakeholders and suppliers to drive results for Regeneron
• The candidate should demonstrate experience supporting cross‑functional teams to drive results in SCARs, ASLs, CAPAs, Change Notifications, and related Quality and Compliance processes

To be considered for this role you must possess a bachelor's degree in a relevant field of study plus 2 years experience in cGMP environment in quality, compliance and/or procurement, including experience in Pharma/BioPharma.

Work experience within a biopharmaceutical company preferred. Microsoft Office required including strong PowerPoint and Excel skills.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.

Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on‑site policy and expectations for your role and your location.

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.