New · posted Nov 5
Regeneron · Biotechnology
Supervisor Quality Control Lab Operations
- Rensselaer, NY
- On-site
- Full-time
- Manager
The role
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 Supervisor of Quality Control (QC) Lab Operations to support our new, highly automated drug substance manufacturing facility. The Supervisor leads a team that manages the technical and operational lifecycle of QC laboratories, including new builds, fit-outs, relocations, technology implementation, and ongoing capability upgrades. Maintaining a portfolio-level view of lab demand, capacity, equipment, data flow, and staffing, the Supervisor sets priorities that align with QC and site objectives. They are accountable for the quality, schedule, and compliance of team deliverables (qualification packages, CSV support, SOPs, and analyst readiness), partner with cross-functional teams, and apply FDA cGMP and ALCOA+ expertise to keep changes inspection-ready and represent the team in inspections and audits.
What you need
This role requires
- BS/BA in Life Sciences, Chemistry, or Engineering discipline and 5+ years of experience; or an equivalent combination of education and experience
- Previous experience with at least one laboratory build, relocation, major fit-out, or significant technology implementation from requirements through handover
- Previous people leadership/ supervisory experience
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.
What you'll do
Discover your role
- Hire, onboard, and develop team; define individual development plans tied to technical and leadership competencies
- Set goals, provide ongoing coaching and feedback, and conduct performance reviews; address performance gaps through documented coaching and improvement plans
- Maintain training compliance for direct reports and a team skills matrix covering equipment qualification, CSV, LIMS and CDS integration, and GMP document authorship
- Maintain the integrated portfolio of lab builds, technology implementations, and upgrades scope, schedule, resource loading, and cross-project dependencies
- Review scoping and business cases developed by the team; recommend prioritization and funding requests to QC management
- Track achievements and first-test dates; report status, risks, and resource constraints to QC leadership and site partners
- Coordinate implementation timing with lab leaders to protect testing capacity and release timelines during installation, qualification, and cutover
- Review User Requirement Specifications, assay-to-space models, material and sample flow designs, and integration requirements for technical completeness and consistency across areas
- Set a consistent standard for lab bus, LIMS, and CDS integration requirements across the portfolio so that data integrity controls are built into design rather than remediated after installation
- Serve as the technical escalation point for issues during installation, FAT and SAT, qualification, and post-handover support
- Verify team deliverables meet cGMP, 21 CFR Part 11, EU Annex 11, and site data integrity requirements before routing for QA review and approval
- Apply knowledge of equipment qualification (IQ/OQ/PQ), computerized system validation, and laboratory system integration, including CDS, LIMS, instrument interfacing, and networked data acquisition
- Responsible for change controls, deviations, and CAPAs initiated by or assigned to the team; monitor investigation quality and closure timeliness
- Oversee data integrity risk and gap assessments across the portfolio and track remediation actions to closure
- Partner with lab leadership to evaluate emerging laboratory technologies, including automation, sample management, and digital integration, against current and projected operational needs
Pay and benefits
$80,300 – $131,300 a year
Employer provided$80,300.00 - $131,300.00
Annual bonuses or incentive plans
Equity awards
401(k) company match
Health and wellness programs
Medical, dental, vision, life and disability insurance
Paid time off
Where you'll work
Rensselaer, NYOn-siteOpen in Maps (opens in a new tab)
More jobs in Rensselaer, NYWorking conditions
When & where
- Location: Rensselaer, New York, United States
- Work model: Monday-Friday, 8am-4:30pm
- Travel: 50% domestic, mostly capital region
Equal opportunity, accessibility and legal noticesRegeneron's statements, word for word
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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.
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
This role's midpoint is 6% below the US median for Quality Control roles at this level.
This roleEmployer provided
Manager roles in New York5 roles publishing pay
Manager roles in the US27 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $80,300 | — | $131,300 |
| New York (middle half) | $104,000 | $105,500 | $105,500 |
| All US (middle half) | $103,250 | $113,000 | $132,750 |
This role: Regeneron's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 245 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Regeneron's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Lab testing and methods7
- Validation and qualification5
- Data and digital systems5
- Documentation and SOPs4
- GMP and compliance3
- Investigations and CAPA1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Control work in biotechnology, led by the four this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signaturesNamed in the posting
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validationNamed in the posting
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug products
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
Company hiring pulse
Regeneron on Regulatory Jobs
- 172
- Open roles
- 147
- Distinct roles
- 11
- Locations
By discipline
- Quality72 42%
- Clinical71 41%
- Regulatory29 17%
By level
- Associate & Specialist55 32%
- Director51 30%
- Manager51 30%
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Supervisor Quality Control Lab Operations at Regeneron
Open until filled. $80K–$131K a year, employer provided.