Stellenbeschreibung
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.
When & where:
Location: East Greenbush, NY
Work model: Monday-Friday, 8am-4:30pm
Discover your role:
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.
This role requires:
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.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or 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. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$172,200.00 - $286,900.00