Sr Mgr SC & Logistics Global Compliance

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 140,000 - 180,000; Full time

Job summary

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.

Qualifications

• 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

Responsibilities

• 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

Skills

Team leadership

Regulatory compliance

Root cause analysis

CAPA management

cGMP knowledge

Education

BS/BA degree

Tools

QUMAS

Job description

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Supply Chain Compliance Manager to join our IOPS Supply Chain and Logistics team, managing and overseeing all compliance-related activities - including investigations, change controls, and CAPA - across Supply Chain and Logistics operations at IOPS sites globally. In this role, you will lead and develop a compliance team, drive inspection readiness, and build a proactive compliance culture - while serving as a go-to technical mentor and collaborating with Quality, Regulatory, and cross-functional partners across the organization. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Location: Troy, New York

Work model: Monday - Friday 8am - 4:30pm, onsite

Travel percentage: 25% to Ireland

Discover your role:

• 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

This role requires:

• 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

Does this sound like you?

We are committed to building a workplace with an inclusive culture. 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, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, addit