Senior Manager Quality Control, Lab Operations

Regeneron Pharmaceuticals, Inc.; City of Saratoga Springs (NY); On-site; USD 170,000 - 230,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Rensselaer, NY seeks a Senior Manager, QC Lab Operations to lead a growing QC lab team across facilities, equipment, and digital integration. You will guide strategy for lab design, qualification, data integrity, and regulatory readiness, ensuring cGMP compliance and ALCOA+ data practices.

You will manage hiring, training, and development while partnering with Engineering, QA, and IT to optimize testing capacity, scheduling, and capital investments.

Qualifications

• Led or held a core role on a build, relocation, fit-out, or major technology implementation.
• Experience supporting GMP inspections or internal audits, including presenting and defending records.
• Experience leading QC lab technology delivery and site-wide implementation standards.

Responsibilities

• Lead and develop a larger team, ownership of organizational design and workforce strategy for QC lab facilities.
• Set competency framework and accountable for coaching, performance, and employee relations outcomes.
• Ensure training compliance and site-wide skills strategy (equipment qualification, CSV, LIMS/CDS integration).
• Lead lab builds, technology implementations, upgrades, and manage capital spend and schedules.
• Set prioritization criteria and sponsor business cases tied to site strategy.
• Represent QC Lab Operations in design reviews with executives and cross-functional partners.
• Be a senior escalation point for issues during installation, FAT/SAT, qualification, and handover.

Skills

People leadership

Cross-functional collaboration

GMP & regulatory readiness

Project management

Strategic lab operations

Data integrity & ALCOA+

Education

BS/BA in Life Sciences, Chemistry, Engineering or related field

Job description

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
• Previous people leadership/ supervisory experience
• 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

Does this sound like you?

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 pro