Supply Compliance Analyst

Location

Raheen, Limerick

Key Responsibilities

• Develop and implement a compliance framework for all Supply Chain departments, including policies and procedures.
• Act as liaison between Supply Chain departments and onsite quality and regulatory groups to resolve non compliance issues.
• Facilitate reviews and revisions of SOPs, plans, and policies across the department.
• Support sub groups and supervisors with the initiation, review, submission, and follow up of documents such as CCs, NOEs, DNFs, impact statements, and corrective action plans.
• Drive a proactive compliance environment through self audits, knowledge transfer, and education on compliance matters.
• Complete documentation, forms, and pre work related to change controls and investigations.
• Collaborate with other functional groups to assess impact, obtain necessary reviews, and secure approvals for investigations.
• Ensure investigation activities and resolution of non conformities are performed timely and in compliance with Regeneron procedures and regulatory requirements.
• Lead or participate in the investigation process and write or review investigation reports.
• Ensure Corrective & Preventive Actions are appropriate, implemented as planned, and effective.

Qualifications

• Associate Analyst: Bachelor's degree in Business, Supply Chain Management, Science, or equivalent education/experience.
• Analyst: Bachelor's degree in Business, Supply Chain Management, Science, and 2 years of experience in a cGMP environment.
• Senior Analyst: Bachelor's degree in Business, Supply Chain Management, Science, and 5 years of experience in investigations or change controls in a cGMP environment.
• Preferred: Experience in a cGMP environment and in the pharmaceutical or biotech industry.
• Knowledge of lean/continuous improvement and APICS or related purchasing certifications is a plus.
• Strong analytical, organizational, and prioritization skills; able to manage ambiguity and adapt to change.
• Proficiency in MS Office, Excel, and PowerPoint, and database skills.

Equal Opportunity Statement

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, reasonable accommodation will be provided to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.