Senior QC Lab Operations Leader

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 129,000 - 210,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager of Quality Control, Lab Operations to lead a growing QC laboratory team at our new highly automated drug substance facility. The role sets strategy for lab operations, ensuring cGMP compliance and data integrity across URS, LIMS, and CDS integrations.

You will oversee hiring, training, performance management, and development, while standardizing lab implementation practices across sites. Travel up to 50% is required.

Qualifications

• BS/BA in Life Sciences, Chemistry, Engineering or a related field.
• Previous people leadership/ supervisory experience.
• Led or played 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 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.

Skills

People leadership

Cross-functional collaboration

Regulatory inspections support

Quality systems thinking

Education

BS/BA in Life Sciences or related field

Tools

LIMS

CDS integration

CSV/ Computer system validation

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager of Quality Control, Lab Operations to lead a growing QC laboratory team at our new highly automated drug substance facility. The role sets strategy for lab operations, ensuring cGMP compliance and data integrity across URS, LIMS, and CDS integrations.

You will oversee hiring, training, performance management, and development, while standardizing lab implementation practices across sites. Travel up to 50% is required.