Director, External Manufacturing Compliance

Role Summary

Director of External Manufacturing Compliance is responsible for supervising 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. This role is 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 operations for 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 Operations Steering Committees
• Oversee Inspection Readiness strategies for regulatory inspections or quality audits involving outsourced manufacturing; provide on-site support to CMO/Partner sites and internal Regeneron audits
• Offer expertise to the global External Manufacturing organization on cGMP 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

• Role requires a Bachelor’s degree
• Director – 12+ years of pharmaceutical aseptic manufacturing experience in compliance, quality assurance, or manufacturing-related roles; Sr Director – 15+ years (may substitute proven experience for education)
• Experience interacting with Contract Manufacturing Organizations and leading in the Compliance/QA/QC field
• Knowledge of industry practices and regulations (cGMP, Annex I) and multiple health authorities (FDA, EMA, MHRA, etc.)
• Strong leadership with focus on team growth and staff development
• Proficiency in German, French and/or Spanish (oral and written) is a plus

Skills

• Proactive issue resolution and ability to work across departments and with business partners
• Excellent interpersonal, cross-cultural, communication and problem-solving skills
• Ability to work with CMOs and lead in Compliance/QA/QC

Education

• Bachelor’s degree required