Director, Manufacturing Compliance (Fill/Finish)

About the role

The Director of Manufacturing Compliance will lead and develop the Fill/Finish Manufacturing compliance organization, overseeing Change Control, Manufacturing Investigations, and CAPA management functions. This role serves as the primary compliance interface between Fill/Finish Manufacturing and IOPS-level quality, regulatory, and governance bodies.

Responsibilities

• Directly oversees the Fill/Finish Change Control program, ensuring timely, risk-based evaluation of all manufacturing changes across equipment, processes, materials, facilities, and systems.
• Directly oversees the Manufacturing Investigations and CAPA program, including deviation management, root cause analysis, effectiveness checks, and timely closure of GMP events originating from fill/finish operations.
• Maintains site inspection readiness and represents the manufacturing compliance function during regulatory and client audits; participates in cGMP audits of all production areas.
• Represents Fill/Finish Manufacturing at compliance meetings, governance forums, and health authority interactions; leads escalation response for manufacturing compliance issues.
• Partners with Fill/Finish Operations leadership in a supporting capacity to provide compliance guidance on process challenges, validation activities, and new technology introductions.
• Drives a culture of continuous compliance improvement, monitors team KPIs, and ensures the sustained inspection readiness of fill/finish operations.
• Conducts trend analysis across investigations and deviations to identify recurring failure modes and systemic improvement opportunities.
• Writes, reviews, and/or approves SOPs, specifications, regulatory filings, and other controlled documents; executes QMS assignments (CAPA, Deviation, Investigation, Change Control).

Requirements

• BS/BA in any of the physical or biological sciences, or chemical engineering and 12+ years of industry experience or equivalent combination of education and experience.
• Demonstrated compliance leadership with experience leading multi-tiered QMS functions (Change Control, Investigations, CAPA) in an aseptic biologics GMP manufacturing environment; multiproduct facility experience preferred.
• Deep working knowledge of GMP regulations (FDA 21 CFR Parts 210/211, EU GMP Annex 1, ICH Q10) and experience interacting with multiple health authorities (e.g., FDA, EMA, PMDA).
• Proven ability to lead cross-functional and direct-report teams; excellent at collaborating across Quality Assurance, Facilities, Supply Chain, Regulatory Affairs, and Engineering to remove barriers and build alignment.
• Effective communicator across all organizational levels, from frontline manufacturing teams to IOPS Senior Leadership and health authority representatives.
• Strategic thinker who can solve complex compliance challenges, quickly adapt to emerging situations, and interpret data to drive decisions and promote organizational health.

Qualifications

• BS/BA in any of the physical or biological sciences, or chemical engineering and 12+ years of industry experience or equivalent combination of education and experience.
• Proven experience leading multi-tiered QMS functions (Change Control, Investigations, CAPA) in an aseptic biologics GMP manufacturing environment; multiproduct facility experience preferred.
• Deep understanding of GMP regulations (FDA 21 CFR Parts 210/211, EU GMP Annex 1, ICH Q10) and experience interacting with multiple health authorities (e.g., FDA, EMA, PMDA).
• Strong leadership and collaboration skills, able to work effectively across departments including Quality Assurance, Facilities, Supply Chain, Regulatory Affairs, and Engineering.
• Excellent communication skills, both written and verbal, with the ability to communicate with all levels of the organization and external stakeholders.
• Strategic thinker with the ability to solve complex compliance challenges, adapt to changing situations, and interpret data to drive decisions and promote organizational health.

Skills

• Compliance leadership and experience in a GMP manufacturing environment.
• Experience with GMP regulations and interaction with health authorities.
• Leadership and collaboration skills.
• Effective communication skills.
• Strategic thinking and problem-solving abilities.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

Pay

$172,200.00 - $286,900.00 annually

Schedule

Monday-Friday, 8am-4:30pm