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 drivewhat 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."

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 :

• Establish user requirements and best practices to enhance laboratory operations, reduce cycle times, and boost efficiency
• Identify and assess opportunities for improving the LIMS implementation process
• Develop, implement, and review validation protocols, SOPs, test scripts, and training materials for LIMS
• Configure, customize, maintain, and upgrade the LIMS system
• Develop Master Data templates for LIMS
• 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 fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).