Senior Manager Quality Control, Lab Operations

BioSpace; City of Saratoga Springs (NY); Presencial; USD 129.000 - 210.000; Tempo integral

Resumo da vaga

Regeneron is hiring a Senior Manager, Quality Control (QC) Lab Operations to lead and evolve QC laboratories at our new, highly automated drug substance facility in the US. The role shapes the operational lifecycle of QC labs, including new builds, fit-outs, relocations, technology implementations, and data integrity.

You will drive staffing, training, and performance standards across sites. Located in Rensselaer, NY, this role requires 8+ years of leadership in life sciences, a strong

Qualificações

• BS/BA in Life Sciences or related field and 8+ years of experience.
• Leadership experience managing teams.
• Experience delivering lab builds, relocations, or major tech implementations from requirements through handover.
• Experience supporting GMP inspections or internal audits, including presenting and defending records.

Responsabilidades

• Lead and develop a larger QC lab team and staffing strategy.
• Set competency framework and coach managers.
• Ensure training compliance and site-wide skills strategy.
• Oversee lab builds, technology implementations, and upgrades.
• Set prioritization criteria and allocate resources across portfolios.
• Represent QC Lab Operations at executive and cross-functional forums.
• Lead change control, deviation, and CAPA processes.
• Ensure cGMP, 21 CFR Part 11, and data integrity requirements.

Conhecimentos

People leadership

GMP compliance

Budget planning

Project management

Regulatory inspections

Formação

BS/BA in Life Sciences

Ferramentas

LIMS

CDS

Descrição da vaga

Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Were 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.

Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Were 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 QCs 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 functions 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.

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 onsite.

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