Senior Manager Quality Control, Lab Operations

Regeneron Pharmaceuticals • Saratoga Springs, UT

22h • $128,800 - $210,200 • Onsite

About The Position

Regeneron is hiring a Senior Manager, QC Lab Operations to support teams at its highly automated drug substance manufacturing facility. The role leads the technical and operational lifecycle of assigned QC laboratories, including new builds, fit-outs, relocations, technology implementations, and capability upgrades. It sets laboratory operations strategy based on testing demand, equipment utilization, capacity, sample and data flow, and staffing, while partnering with internal stakeholders to address 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, and oversees hiring, training, performance management, and employee development. It also standardizes laboratory implementation practices across sites.

The Senior Manager leads organizational design, headcount planning, workforce strategy, and the integrated portfolio of laboratory projects. It establishes technical and quality standards for laboratory delivery and integrations, oversees compliance and change-control performance, and represents QC in executive and cross-functional forums. The role partners with QC and site leadership on the multi-year technology roadmap and uses performance metrics and trends to guide resources, processes, and investment decisions.

The position is based in Rensselaer, New York. The stated schedule is Monday through Friday, 8:00 a.m. to 4:30 p.m., with 50% domestic travel, mostly in the Capital Region. The posting notes that many Regeneron roles are required to be performed on-site; applicants should confirm the expectations for this role with the recruiter and hiring manager.

Requirements

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field.
• At least 8 years of experience.
• Previous people leadership or supervisory experience.
• Have led, or held a core role on, a build, relocation, major fit-out, or significant technology implementation from requirements through handover.
• Experience supporting GMP inspections or internal audits, including presenting and defending records.

Responsibilities

• Lead and develop a larger team; own organizational design, headcount planning, and workforce strategy for QC laboratory technology and facilities delivery.
• Build the leadership pipeline through talent calibration and stretch assignments; set the competency framework for managers and hold them accountable for team performance, coaching quality, and employee relations outcomes.
• Ensure training compliance and establish a site-wide skills strategy covering equipment qualification, CSV, LIMS and CDS integration, and GMP authorship; identify capability gaps.
• Lead the integrated portfolio of laboratory builds, technology implementations, and upgrades, with accountability for capital and project spend, schedule, and resource allocation.
• Set prioritization criteria, balance resources across managers’ portfolios, resolve cross-portfolio conflicts, sponsor business cases, and recommend scope trade-offs tied to site strategy.
• Serve as QC’s design authority for laboratory technology delivery; set standards for URS content, assay-to-space and material-flow design, and laboratory bus, LIMS, and CDS integration.
• Represent QC Lab Operations at executive and cross-functional forums on design, vendor strategy, and value engineering; own QC’s position on scope reductions.
• Serve as a senior escalation point for critical issues during installation, FAT and SAT, qualification, and post-handover support; make risk-based decisions with Engineering, QA, and IT.
• Ensure deliverables comply with cGMP, 21 CFR Part 11, EU Annex 11, and site data integrity requirements; define quality gates managers apply before QA review.
• Lead change control, deviation, and CAPA performance; set expectations for investigation quality and closure timeliness; own the data integrity gap assessment and remediation roadmap and report progress to QC and QA leadership.
• Serve as a senior spokesperson in regulatory inspections and internal audits; prepare managers and subject matter experts to defend qualification and implementation records.
• Set standard templates, work instructions, and delivery methods across project types, and incorporate 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 performance metrics, including on-time breakthrough delivery, right-first-time qualification, and post-handover issue rate, and use trends to guide resource, process, and investment decisions.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior