Sr. Manager, QC LIMS Administrator

Role Summary

The Sr. Manager, QC LIMS Administrator is a subject matter expert responsible for configuring, maintaining, and optimizing the LIMS platform to support Quality Control laboratory operations. The role collaborates with stakeholders across IT, Analytical Development, Quality Control, Quality Assurance, and Computer System Validation to deliver compliant, efficient, and user-friendly system solutions. The LIMS Administrator leads system configuration projects, supports data integrity initiatives, manages routine updates, and provides user training to enable reliable and streamlined laboratory operation. This role is based in Waltham, MA.

Responsibilities

• Lead the configuration, maintenance, and enhancement of QC workflows within the LIMS platform
• Translate user and business requirements into effective, compliant system solutions and workflows
• Develop and execute projects and implement plans to ensure timely delivery of enhancements
• Own and manage change controls, deviations, and other quality records related to LIMS
• Serve as QC lead for metadata management, reporting, and data structure updates
• Author and deliver end-user procedures, training materials, and hands-on training sessions
• Support system upgrades, validation activities, and ensure ongoing system compliance with regulatory requirements
• Generate and manage LIMS data reporting and support data queries from business partners
• Partner with IT and vendors to troubleshoot, escalate, and resolve LIMS issues
• Support internal and external audits by ensuring data integrity and system compliance with applicable regulations

Qualifications

• Required: Bachelor‚Äôs degree in Life Sciences, Computer Science, Information Technology, or a related field with 8+ years of relevant experience in the life sciences, biotech, or pharmaceutical industry
• Required: Strong understanding of QC laboratory workflows, analytical instrumentation, and data management principles
• Required: In-depth knowledge of data integrity regulations and guidelines (21 CFR Part 11, Computer System Validation, ALCOA)
• Required: Proven hands-on experience in LIMS administration, configuration, implementation, and validation
• Required: Ability to translate user requirements into efficient system workflows and develop creative solutions within platform constraints
• Required: Excellent communication skills with the ability to train and support staff across multiple levels and functions
• Required: Demonstrated project management experience and ability to work in a fast-paced, collaborative environment
• Preferred: Comfortable in an adaptable small company environment with minimal direction and ability to adjust workload based upon changing priorities
• Preferred: Strong commitment to ethical standards
• Preferred: Proficient with Microsoft Office suite (Word, PowerPoint, Excel, Outlook, SharePoint)
• Preferred: Ability to travel up to 5%