Quality Control Operations Specialist

Role Summary

Regeneron is looking for an Operations Specialist in Quality Control. This role serves as the single point of contact for counterpart teams, represents QC in cross-functional forums, and proactively monitors Certificates of Analysis (CoAs), testing progress, data review, and investigations. Using proven operational management techniques and deep QC domain knowledge, the Operations Specialist orchestrates activities across Quality Control to deliver on-time testing and QC outputs that enable batch release and key program milestones.

Responsibilities

• Monitors end-to-end progress of QC deliverables (testing, data review, investigations, CoAs) and coordinates resources and cross-functional communication to meet target dates.
• Coordinates QC for new modalities (e.g., cell and gene therapies, mRNA/LNP products, viral vectors, oligonucleotides, biologics), including modality-specific test panels and turnaround times.
• Maintains a real-time view of Work in Progress (WIP); tracks backlog, priorities, dependencies, and critical path to enable realistic scheduling and optimal resource alignment.
• Leverages a proficient understanding of QC processes and digital tools (e.g., LIMS, ELN, LES, chromatography data systems, eQMS, and business productivity/reporting tools) to manage work and communicate status.
• Uses dashboards and trackers to set clear, justified due dates for QC activities; navigates competing priorities and constructively challenges assumptions when needed.
• Proactively identifies team performance issues and process bottlenecks; drives issue management, escalations, and recovery plans to protect critical milestones.
• Builds strong working relationships with QC functional owners and cross-functional partners; facilitates efficient handoffs and transparent communication.

Qualifications

• You’re familiar with relevant analytical and microbiological QC methods and data review expectations for advanced therapeutics.
• You have experience with digital QC systems (LIMS, ELN/LES, CDS, eQMS) and visualization tools (e.g., Power BI, Tableau).
• You can demonstrate contributions to continuous improvement initiatives (Lean, Six Sigma, Kaizen) within QC or laboratory operations.
• BS/BA in life sciences, or a related field.
• Level will be determined based on qualifications.
• Specialist: Requires BS/BA and a minimum of 2+ years of industry experience.
• Senior Specialist: Requires BS/BA and 5+ years of industry experience, including 2 years in Quality Control or other laboratory experience.