Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We’re hiring a Senior Manager Quality Control (QC) Lab Operations to support our teams at our new highly automated drug substance manufacturing facility. The Senior Manager, QC Lab Operations leads a team who supports the technical and operational lifecycle of assigned QC laboratories, including new lab builds, fit-outs, relocations; new technology implementation; and continuous capability upgrades. The role sets strategy for lab operations, accounting for testing demand, equipment utilization, capacity, sample and data flow, and staffing. They partner with internal partners to resolve cross-functional conflicts and schedule, resource, and compliance risks. The role ensures changes meet FDA cGMP requirements and ALCOA+ data integrity principles. Represents the team during regulatory inspections and internal audits. Oversees hiring, training, performance management, and development of team members while standardizing lab implementation practices across sites.
When & where:
Location: Rensselaer, New York, United States
Work model: Monday-Friday, 8am-4:30pm
Travel: 50% domestic- mostly capital region
Discover your role:
Lead and develop a larger team, own organizational design, headcount planning, and workforce strategy for QC lab technology and facilities delivery
Build the leadership pipeline through talent calibration and stretch assignments; set the competency framework managers apply, and hold them accountable for team performance, coaching quality, and employee relations outcomes
Ensure training compliance and a site-wide skills strategy (equipment qualification, CSV, LIMS and CDS integration, GMP authorship); identify capability gaps
Lead the integrated portfolio of lab builds, technology implementations, and upgrades, with accountability for capital and project spend, schedule, and resource allocation
Set prioritization criteria, balance resources across managers’ portfolios, and resolve cross-portfolio conflicts; sponsor business cases and scope trade-off recommendations tied to site strategy
Serve as QC’s design authority for lab technology delivery; set standards for URS content, assay-to-space and material flow design, and lab bus, LIMS, and CDS integration so data integrity is designed in rather than remediated later
Represent QC Lab Operations at executive and cross-functional forums on design, vendor strategy, and value engineering; own the QC position on any scope reduction
Act as senior escalation points for critical issues during installation, FAT and SAT, qualification, and post-handover support; make risk-based decisions with Engineering, QA, and IT
Accountable for deliverable compliance with cGMP, 21 CFR Part 11, EU Annex 11, and site data integrity requirements; define the quality gates managers apply before QA review
Lead all aspects of change control, deviation, and CAPA performance; set expectations for investigation quality and closure timeliness; own the data integrity gap assessment and remediation roadmap, reporting progress to QC and QA leadership
Serve as senior spokesperson in regulatory inspections and internal audits; prepare managers and SMEs to defend qualification and implementation records
Set standard templates, work instructions, and delivery methods across all project types, and institutionalize lessons learned into standards, planning assumptions, and vendor strategy
Partner with QC and site leadership on the multi-year technology roadmap, assessing automation, sample management, and digital integration against projected demand
Define the function’s performance metrics (on-time breakthrough delivery, right-first-time qualification, post-handover issue rate) and use trends to drive resource, process, and make investment decisions
This role requires:
BS/BA in Life Sciences, Chemistry, Engineering or a related field and 8+ years of experience
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