Director, Manufacturing Compliance (Fill/Finish)

Regeneron Pharmaceuticals•Rensselaer, NY

29d•$172,200 - $286,900•Onsite

About The Position

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director of Manufacturing Compliance who will be accountable for leading and developing the Fill/Finish Manufacturing compliance organization, with direct oversight of 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 — representing the manufacturing function in all compliance escalations, health authority interactions, and cross-functional governance forums. The Director drives a culture of continuous compliance improvement, monitors team KPIs, and ensures the sustained inspection readiness of fill/finish operations. In a supporting and partnering capacity, this role maintains close collaboration with Fill/Finish Operations leadership to align compliance priorities with production objectives and patient supply commitments. This is a leadership role requiring deep GMP expertise, organizational effectiveness, and the ability to lead multi-tiered compliance teams.

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).
Must have a sustained mindset for inspection readiness; proven ability to develop and monitor compliance KPIs and translate data trends into actionable improvement strategies.
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.
Excellent at developing staff, teams, and future compliance leaders; leads by example with a passion for continuous improvement and critical thinking.
Strategic thinker who can solve complex compliance challenges, quickly adapt to emerging situations, and interpret data to drive decisions and promote organizational health.

Nice To Haves

Multiproduct facility experience preferred.

Responsibilities

Provides leadership, vision, and management to the Manufacturing Compliance & Services team, with direct oversight of Change Control and Manufacturing Investigations sub-teams.
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.
Monitors, manages, and reports team KPIs across all compliance sub-functions; presents performance metrics to site and IOPS leadership on a recurring cadence.
Conducts trend analysis across investigations and deviations to identify recurring failure modes and systemic improvement opportunities.
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.
Leads annual merit performance reviews, develops long-term staffing plans, and collaborates with Directors on annual budget development.
Rapidly communicates compliance risks to department Directors and Senior Leadership; resolves issues to mitigate patient supply disruptions.
Works effectively across departments including Quality Assurance, Facilities, Engineering, MSAT, Regulatory Affairs, Quality Control, IT, and Supply Chain.
Writes, reviews, and/or approves SOPs, specifications, regulatory filings, and other controlled documents; executes QMS assignments (CAPA, Deviation, Investigation, Change Control).
Maintains site inspection readiness and represents the manufacturing compliance function during regulatory and client audits; participates in cGMP audits of all production areas.