Manager, QC LIMS

Position Overview

The Manager, QC Laboratory Information Management System (LIMS) is responsible for developing strategic plans for implementing FDB's global Laboratory Information Management System (LIMS). This role harmonizes processes across all current and future FDB sites and leads the transition of QC into a paperless environment. The Manager, QC LIMS guides a team of LIMS experts to translate global and site-specific needs into user requirements, system design, configuration, and implementation plans. This role acts as the primary subject matter expert (SME) for LIMS and focuses on maintaining and continuously enhancing the global LIMS system.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You'll Do

 

• Provides cross-functional leadership as the recognized LIMS expert• Develops strategic implementation plans, recruits LIMS staff, and manages project budgets• Ensures data integrity principles are at the core of LIMS implementation• Directs the LIMS team to:     o Establish user requirements and best practices to enhance laboratory operations, reduce cycle times, and boost efficiency     o Identify and assess opportunities for improving the LIMS implementation process     o Develop, implement,, and review validation protocols, SOPs, test scripts, and training materials for LIMS     o Configure, customize, maintain, and upgrade the LIMS system     o Develop Master Data templates for LIMS     o Provide support and training to new users for data entry and reporting• Manages and prioritizes the workload and responsibilities of the LIMS team• Provides guidance and support to less experienced team members• Identifies and implements system improvements• Integrates quality and regulatory compliance into LIMS design• Prepares and delivers presentations to both internal and external stakeholders• Manages and develops direct reports from LIMS team• Administers company policies such as time off, shift work, and inclement weather that directly impact employees• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)• Coaches and guides direct reports to foster professional development• Participates in the recruitment process and retention strategies to attract and retain talent, as needed• Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution• Performs other duties, as assigned.

 

Minimum Requirements:

 

• Bachelor’s degree with 7+ years of experience in a GMP environment and LIMS experience in pharmaceutical industry OR• Master’s degree with 5+ years of experience in a GMP environment and LIMS experience in pharmaceutical industry OR• PHD with 3+ years of experience in a GMP environment and LIMS experience in pharmaceutical industry

• 2-5 years of people management experience• Proven experience in full life cycle implementation of multi-site LIMS• Proven experience in connecting analyzers to the LIMS and ability to provide a roadmap from Development to QC.• Extensive knowledge of GMPs, computer system software development and validation, with the ability to apply to non-routine situations.• Deep understanding and command of LIMS requirements.

 

Preferred Requirements:

 

• Experience in LabWare v8

 

Physical and Work Environment Requirements:

 

 

Ability to discern audible cues.

Ability to ascend or descend ladders, scaffolding, ramps, etc.

Ability to stand for prolonged periods of time up to 120 minutes

Ability to sit for prolonged periods of time up to 120 minutes

Ability to conduct activities using repetitive motions that include writs, hands and/or fin