Director, Manufacturing Compliance (Fill/Finish)
Regeneron
August 07, 2026
On-site
East Greenbush, NY
Operations
Discover Your Role
- Provide leadership, vision, and management to the Manufacturing Compliance & Services team, with direct oversight of Change Control and Manufacturing Investigations sub-teams.
- Oversee the Fill/Finish Change Control program, ensuring timely, risk-based evaluation of manufacturing changes across equipment, processes, materials, facilities, and systems.
- Oversee the Manufacturing Investigations and CAPA program, including deviation management, root cause analysis, effectiveness checks, and timely closure of GMP events from fill/finish operations.
- Monitor, manage, and report team KPIs; present performance metrics to site and IOPS leadership.
- Conduct trend analysis across investigations and deviations to identify recurring failure modes and systemic improvement opportunities.
- Represent Fill/Finish Manufacturing in compliance meetings, governance forums, and health authority interactions; lead escalation response for manufacturing compliance issues.
- Partner with Fill/Finish Operations on compliance guidance for process challenges, validation activities, and new technology introductions.
- Lead annual merit performance reviews, develop long-term staffing plans, and collaborate on annual budget development.
- Rapidly communicate compliance risks and resolve issues to mitigate patient supply disruptions.
- Write, review, and/or approve SOPs, specifications, regulatory filings, and controlled documents; execute QMS assignments (CAPA, Deviation, Investigation, Change Control).
- Maintain site inspection readiness; represent the function during regulatory/client audits and participate in cGMP audits.
This Role Requires
- BS/BA in physical/biological sciences or chemical engineering plus 12+ years of industry experience (or equivalent).
- Demonstrated compliance leadership leading multi-tiered QMS functions (Change Control, Investigations, CAPA) in aseptic biologics GMP; multiproduct facility experience preferred.
- Deep working knowledge of GMP regulations (FDA 21 CFR Parts 210/211, EU GMP Annex 1, ICH Q10) and experience with health authorities (e.g., FDA, EMA, PMDA).
- Sustained inspection-readiness mindset; ability to develop/monitor compliance KPIs and translate trends into actions.
- Ability to lead teams and collaborate cross-functionally (Quality Assurance, Facilities, Supply Chain, Regulatory Affairs, Engineering, etc.).
- Effective communication across all organizational levels; strong staff/team development.
- Strategic thinker who can solve complex compliance challenges and adapt quickly.
Application Instructions
- Apply now.
- Provide leadership, vision, and management to the Manufacturing Compliance & Services team, with direct oversight of Change Control and Manufacturing Investigations sub-teams.
- Oversee the Fill/Finish Change Control program, ensuring timely, risk-based evaluation of manufacturing changes across equipment, processes, materials, facilities, and systems.
- Oversee the Manufacturing Investigations and CAPA program, including deviation management, root cause analysis, effectiveness checks, and timely closure of GMP events from fill/finish operations.
- Monitor, manage, and report team KPIs; present performance metrics to site and IOPS leadership.
- Conduct trend analysis across investigations and deviations to identify recurring failure modes and systemic improvement opportunities.
- Represent Fill/Finish Manufacturing in compliance meetings, governance forums, and health authority interactions; lead escalation response for manufacturing compliance issues.
- Partner with Fill/Finish Operations on compliance guidance for process challenges, validation activities, and new technology introductions.
- Lead annual merit performance reviews, develop long-term staffing plans, and collaborate on annual budget development.
- Rapidly communicate compliance risks and resolve issues to mitigate patient supply disruptions.
- Write, review, and/or approve SOPs, specifications, regulatory filings, and controlled documents; execute QMS assignments (CAPA, Deviation, Investigation, Change Control).
- Maintain site inspection readiness; represent the function during regulatory/client audits and participate in cGMP audits.
This Role Requires
- BS/BA in physical/biological sciences or chemical engineering plus 12+ years of industry experience (or equivalent).
- Demonstrated compliance leadership leading multi-tiered QMS functions (Change Control, Investigations, CAPA) in aseptic biologics GMP; multiproduct facility experience preferred.
- Deep working knowledge of GMP regulations (FDA 21 CFR Parts 210/211, EU GMP Annex 1, ICH Q10) and experience with health authorities (e.g., FDA, EMA, PMDA).
- Sustained inspection-readiness mindset; ability to develop/monitor compliance KPIs and translate trends into actions.
- Ability to lead teams and collaborate cross-functionally (Quality Assurance, Facilities, Supply Chain, Regulatory Affairs, Engineering, etc.).
- Effective communication across all organizational levels; strong staff/team development.
- Strategic thinker who can solve complex compliance challenges and adapt quickly.
Application Instructions
- Apply now.