Director, External Manufacturing Compliance

Role Summary

Director of External Manufacturing Compliance. This position supervises a team that supports compliance activities for all products manufactured within Regeneron’s External Manufacturing network in accordance with mandated regulatory requirements, Regeneron Quality Systems, and site expectations. Located onsite at the Albany, NY manufacturing facility.

Responsibilities

• Provide leadership and support to prioritize, resource, guide, strategize and deliver upon compliance requirements
• Establish standard processes in all compliance-related activities, collaborate with quality compliance groups, meet goals, and lead External Manufacturing cGMP Policies and SOPs
• Lead and prioritize operations for supporting CMO/Partner Change Notifications, Change Controls, SCARs, Deviations and CAPAs for clinical and commercial manufacturing across External Manufacturing
• Provide performance metrics status and identify continuous improvement needs to CMOs at regular Operations Steering Committees
• Manage Inspection Readiness strategies for regulatory inspections or quality audits involving outsourced manufacturing; provide advice and on-site support to CMO/Partner sites and support internal Regeneron audits
• Provide expertise to the global External Manufacturing organization on cGMP compliance standard processes and evolving regulatory requirements and trends
• Develop, train and coach Compliance and Manufacturing Specialists to lead or support closure of Quality System records
• Collaborate with Quality Assurance and External Manufacturing teams to address observations and drive CAPAs, SCARs, CCs to completion
• Travel up to 40% (domestic and international)

Qualifications

• Required: Bachelor's degree and extensive pharmaceutical aseptic manufacturing experience in compliance, quality assurance, or manufacturing roles (level-based requirements below)
• Director ‚Äì 12+ years; Sr Director ‚Äì 15+ years (may substitute proven experience for education)

Skills

• Strong issue-resolution, cross-department collaboration, and partner management
• Excellent interpersonal, cross-cultural communication and problem-solving skills
• Experience with Contract Manufacturing Organizations and leading in Compliance/QA/QC
• Knowledge of cGMP, Annex I, and multiple health authorities (FDA, EMA, MHRA, etc.)
• Leadership commitment to team growth and staff development
• Proficiency in German, French and/or Spanish is a plus

Education

• Bachelor's degree required; level determined by qualifications relevant to the role