Supervisor Quality Control Lab Operations

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Supervisor of QC Lab Operations for its highly automated drug substance facility in the Capital Region.

You will lead a team responsible for the technical and operational lifecycle of QC laboratories, including qualification packages, CSV support, SOPs, and analyst readiness. The role demands strong leadership, regulatory expertise (FDA cGMP, 21 CFR Part 11, EU Annex 11), and hands-on oversight of lab infrastructure upgrades, LIMS/CDS integration, and data

Qualifications

• 5+ years of experience leading QC lab operations and teams.
• Experience applying FDA cGMP and ALCOA+ principles.
• Proven ability to manage qualification packages, CSV support, SOPs, and analyst readiness.
• Strong collaboration with cross-functional teams to meet quality and scheduling goals.

Responsibilities

• Hire, onboard, and develop team; define development plans tied to technical and leadership competencies.
• Set goals, coach, provide feedback, and conduct performance reviews.
• Maintain training compliance and a skills matrix for equipment qualification, CSV, LIMS and CDS integration.
• Oversee lab portfolio: builds, technology implementations, and upgrade scope, schedule, and resource loading.
• Review scoping and business cases; recommend prioritization and funding requests to QC management.
• Track milestones, report risks and resource constraints to QC leadership.
• Coordinate installation timing to protect testing capacity; ensure release timelines.
• Review User Requirement Specifications and integration requirements for consistency.
• Set standards for lab bus, LIMS, and CDS integration; build data integrity controls into design.
• Serve as escalation point for issues during installation, FAT/SAT, qualification, and post-handover support.
• Ensure compliance with cGMP, 21 CFR Part 11, and EU Annex 11.

Skills

Leadership & People Management

Quality systems & cGMP

Project management

Regulatory compliance

Data integrity

Education

BS/BA in Life Sciences, Chemistry, or Engineering

Tools

LIMS

CDS

Job description

Team: Industrial Operations & Product Supply

Supervisor 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 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.

When & where:

• Travel: 50% domestic, mostly capital region

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

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
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