Compliance Specialist, External Manufacturing

About the Role

This role is responsible for operations support and compliance related activities for the manufacturing of Regeneron products within the External Manufacturing team.

Key Responsibilities

• Lead and manage change controls, SCARs, SCNs, NPCs, and CAPAs.
• Review and maintain procedures, policies, and other instructional documents with a focus on continuous improvement.
• Support both internal and external inspection and audit readiness activities.
• Responsible for periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies, and procedures.
• Maintain required training status on Regeneron specific work instructions and SOPs.
• Continuous process improvement implementation.

Requirements & Tech Stack

• Maintain knowledge of current good manufacturing practices (cGMPs).
• Maintain required training status on Regeneron specific work instructions and SOPs.
• Proficient in Veeva, Opstrakker, Excel, PowerPoint, Visio, Word.
• Experience working within shared work environments.
• Experience in Collaborating With CMOs/CROs is preferred.

Qualifications

• BS/BA in a scientific field.
• Related experience in cGMP manufacturing operations (clinical and/or commercial).
• Associate Specialist: 0-2 years
• Specialist: 2+ years
• Sr Specialist: 5+ years

Level will be determined based on experience.

• Knowledge of drug product manufacturing from formulation through the final package.
• Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
• Strong interpersonal, written and oral communication skills, with an emphasis on technical writing.
• Exhibits confidence.
• High emotional IQ.
• Shows resiliency and flexibility in the face of challenges and adversarial situations.
• Understands and listens to team members and stakeholders needs while supporting productive team environments toward a common objective.

Location

• East Greenbush, New York, United States

Work Schedule

• Monday-Friday, 8am-4:30pm