Senior Manager Quality Control, Lab Operations

Regeneron Pharmaceuticals • Saratoga Springs, NY

3d • Onsite

About The Position

The Senior Manager, Quality Control (QC) Lab Operations leads a team responsible for the technical and operational lifecycle of assigned QC laboratories, including new lab builds, fit-outs, relocations, technology implementations, and continuous capability upgrades. The role sets lab 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 position ensures changes meet FDA cGMP requirements and ALCOA+ data integrity principles and represents the team during regulatory inspections and internal audits.

The role leads organizational design, headcount planning, workforce strategy, talent development, training compliance, and team performance. It directs a portfolio of laboratory projects and technology upgrades, with accountability for capital and project spend, schedules, resource allocation, delivery standards, and quality outcomes. As QC’s design authority for lab technology delivery, the position sets standards for user requirements, assay-to-space and material-flow design, and lab bus, LIMS, and CDS integration.

The Senior Manager is accountable for compliance with cGMP, 21 CFR Part 11, EU Annex 11, and site data integrity requirements. The role leads change control, deviation, and CAPA performance; oversees data integrity assessment and remediation; and prepares managers and subject-matter experts for inspections and audits. It also establishes standard templates, work instructions, delivery methods, performance metrics, and lessons-learned practices, and partners with QC and site leadership on the multi-year technology roadmap.

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. Regeneron indicates that many roles are performed on-site and advises candidates to confirm role-specific expectations with the recruiter or 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.
• 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 lab technology and facilities delivery.
• Build the leadership pipeline through talent calibration and stretch assignments; establish the competency framework managers use and hold managers accountable for performance, coaching, and employee relations outcomes.
• Ensure training compliance and 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, and sponsor business cases and scope trade-off recommendations aligned with 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 lab bus, LIMS, and CDS integration.
• Represent QC Lab Operations at executive and cross-functional forums concerning design, vendor strategy, and value engineering; own the QC position on scope reductions.
• Act 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 for managers to 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 during 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; 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 function 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.
• Oversee hiring, training, performance management, and development of team members while standardizing laboratory implementation practices across sites.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match may be offered, depending on country and role.
• Health and wellness programs may be offered, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability coverage, may be offered, depending on country and role.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

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