Global Supply Chain Compliance Leader

Regeneron Pharmaceuticals, Inc.; United States; Vor Ort; USD 140.000 - 180.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc. in Troy, NY is seeking a Senior Supply Chain Compliance Manager to lead a global team, oversee all compliance activities, and drive inspection readiness across Supply Chain and Logistics operations.

You will manage investigations, change controls, CAPA, risk assessments, and FMEA, while shaping a proactive compliance culture and mentoring cross-functional partners. This role requires 8+ years in a cGMP environment with strong regulatory knowledge.

Qualifikationen

• BS/BA degree with 8+ years of experience, or equivalent combination of education and experience; level determined based on qualifications.
• Experience in a cGMP environment required; pharmaceutical or biotechnology industry experience preferred
• Advanced knowledge of cGMP operations, regulatory and quality requirements, root cause analysis, and risk evaluation methodologies
• Working knowledge of quality systems and software applications such as QUMAS or similar

Aufgaben

• Lead, develop, and guide a global team performing Supply Chain and Logistics compliance activities, fostering a healthy working environment where team members feel valued, respected, and accountable for results
• Manage teams responsible for completing change controls, preparing investigation reports with root cause analysis, product impact assessments, and corrective action recommendations for medium and high severity non-conformances
• Oversee risk assessments and Failure Mode and Effects Analysis (FMEA) activities; ensure Corrective and Preventive Actions are appropriate, implemented as planned, and demonstrate intended effectiveness
• Manage overall regulatory inspection preparation; oversee department liaisons during inspections and coordinate post-inspection activities; drive proactive compliance through self-audits, knowledge transfer, and compliance education
• Develop and implement an effective compliance framework for Supply Chain and Logistics, including policies, procedures, best practice propagation, and SOP review and revision across all groups within the department
• Track and trend compliance activities including investigations and CAPAs to identify improvement opportunities; ensure all training is maintained and documented in accordance with cGMP standards
• Serve as the go-to technical point of contact and mentor for compliance topics including investigations and inspections across the Supply Chain and Logistics team
• Build and maintain a robust training program; provide support to groups and supervisors on the initiation, review, and follow-up of CCs, NOEs, DNFs, impact statements, and corrective action plans

Kenntnisse

Team leadership

Regulatory compliance

Root cause analysis

CAPA management

cGMP knowledge

Ausbildung

BS/BA degree

Tools

QUMAS

Jobbeschreibung

Regeneron Pharmaceuticals, Inc. in Troy, NY is seeking a Senior Supply Chain Compliance Manager to lead a global team, oversee all compliance activities, and drive inspection readiness across Supply Chain and Logistics operations.

You will manage investigations, change controls, CAPA, risk assessments, and FMEA, while shaping a proactive compliance culture and mentoring cross-functional partners. This role requires 8+ years in a cGMP environment with strong regulatory knowledge.