Senior Manager Quality Control, Lab Operations

Regeneron Pharmaceuticals, Inc.

City of Rensselaer (NY)

On-site

USD 129,000 - 210,000

Full time

2 days ago

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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

Team: Industrial Operations & Product Supply

Senior Manager Quality Control, Lab Operations

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:

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 protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$128,800.00 - $210,200.00

We take hiring seriously — because finding the right person for our mission matters as much to us as finding the right company matters to you. Our process is thorough by design: we want every new hire to feel confident they’ve found a place where their work truly matters, and we want to be just as confident we’ve found someone who’ll thrive here. It's a two‑way conversation, not a one‑way interview.

Part of the team

Where You'll Make an Impact

Here, you’ll collaborate with teams across regions to help move our mission forward.

We invest in your health and stability so you can focus on making meaningful impact. Below is a highlight of benefit programs that may be available to you, depending on your country of employment, role, etc.

Medical, dental and vision insurance

Life insurance and disability coverage

Global wellness support & benefits access

Paid time off, personal/flexibility hours and holiday leave