Senior Global Supply Chain Compliance Lead

Regeneron Pharmaceuticals, Inc (USA)

United States

On-site

USD 126,000 - 206,000

Full time

4 days ago
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Benefits offered by this job

Annual bonuses or other incentive plan
Equity awards
Pension or retirement benefits
401(k) company match
Health and wellness programs
Fitness centers
Insurance benefits (medical, dental, 1
Paid time off
Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc (USA) seeks a Senior Supply Chain Compliance Manager to lead a global compliance team across Supply Chain and Logistics, driving investigations, CAPAs, and change controls in a cGMP environment. You will collaborate with Quality, Regulatory and cross-functional partners to build a proactive compliance culture.

You will manage inspection readiness, develop training, and establish robust processes to ensure regulatory alignment and operational excellence across IOPS

Qualifications

  • BS/BA degree with 8+ years of experience or equivalent combination of education and experience.
  • Experience in a cGMP environment.
  • Advanced knowledge of cGMP operations, regulatory and quality requirements.
  • Working knowledge of quality systems and software applications such as QUMAS or similar.

Responsibilities

  • Lead, develop, and guide a global team performing Supply Chain and Logistics compliance activities, including investigations, change controls, and CAPA.
  • Manage teams responsible for change controls, investigation reports with root cause analysis, product impact assessments, and corrective action recommendations for medium and high severity non-conformances.
  • Oversee risk assessments and FMEA activities; ensure corrective and preventive actions are appropriate, implemented, and effective.
  • Manage regulatory inspection preparation; oversee department liaisons during inspections and coordinate post-inspection activities; drive proactive compliance through self-audits and education.
  • Develop and implement a compliance framework for Supply Chain and Logistics, including policies, SOPs, and best practices across all groups.
  • Track and trend compliance activities including investigations and CAPAs; ensure training is maintained and documented per cGMP standards.
  • Serve as the go-to technical contact and mentor for compliance topics across the team.
  • Build and maintain a robust training program; support CCs, NOEs, DNFs, impact statements, and corrective action plans.

Skills

Leadership
Regulatory knowledge
Risk assessment
Root cause analysis
Quality systems

Education

BS/BA degree

Tools

QUMAS

Job description

Regeneron Pharmaceuticals, Inc (USA) seeks a Senior Supply Chain Compliance Manager to lead a global compliance team across Supply Chain and Logistics, driving investigations, CAPAs, and change controls in a cGMP environment. You will collaborate with Quality, Regulatory and cross-functional partners to build a proactive compliance culture.

You will manage inspection readiness, develop training, and establish robust processes to ensure regulatory alignment and operational excellence across IOPS

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