Director, External Manufacturing Compliance

Role Summary

Director of External Manufacturing Compliance responsible for supervising a team that supports compliance activities across Regeneron’s External Manufacturing network, ensuring adherence to regulatory requirements, Quality Systems, and site expectations. This role is onsite at the Albany, NY facility.

Responsibilities

• Provides leadership and support to prioritize, resource, guide, strategize and deliver upon compliance requirements
• Establish standard processes in all compliance related activities, collaborate and partner with quality compliance groups, strategically meet goals and lead External Manufacturing cGMP Policies and SOPs
• Leads and prioritizes operations and practices for supporting CMO and/or Partner Change Notifications, Change Controls, SCARs, Deviations and CAPAs for clinical and commercial manufacturing across External Manufacturing
• Provides performance metrics status and continuous improvement needs to CMOs at regular Operations Steering Committees
• Is responsible for Inspection Readiness strategies in relation to any regulatory inspection or quality audit involving outsourced manufacturing, provides advice and on-site support to CMO /Partner sites during regulatory, provides support to internal Regeneron audits
• Provides expertise to the global External Manufacturing organization on cGMP compliance standard processes, as well as, new and developing cGMP regulatory requirements and trends
• Develops, trains and coaches Compliance and Manufacturing Specialists to lead or support closure of Quality System records
• Collaborates with Quality Assurance, External Manufacturing teams to effectively address observations and drive CAPAs, SCARs, CCs to completion
• Travel up to 40% is required (domestic and international)

Qualifications

• Required: Bachelor’s degree and 12+ years of pharmaceutical aseptic manufacturing experience in compliance, quality assurance or manufacturing related roles for Director level
• Preferred: 15+ years for Sr Director level; may substitute proven experience for education requirement

Skills

• Proactive issue resolution across departments and business partners
• Strong interpersonal, cross-cultural, communication and problem-solving skills
• Experience with Contract Manufacturing Organizations and leadership in Compliance/QA/QC
• Knowledge of cGMP, Annex I, and multiple health authorities (FDA, EMA, MHRA, etc.)
• Leadership and staff development capabilities
• Proficiency in German, French and/or Spanish is a plus

Education

• Bachelor’s degree required

Additional Requirements

• Travel up to 40% (domestic and international)