Supervisor, Quality Control LIMS

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Supervisor for the QC Laboratory Information Management System (LIMS) to lead a small team of LIMS specialists. You will implement and improve LIMS practices, ensuring data integrity and regulatory compliance across the lifecycle, while coordinating cross-functional activities and maintaining alignment with site goals.

Responsibilities include leading implementation roadmaps, validating and documenting processes, and driving continuous

Qualifications

• Bachelor’s degree in Life Sciences (Biology or Microbiology) with 4+ years of relevant experience or Master’s with 2+ years of relevant experience.
• Proven ability to lead teams in a GMP-regulated environment.
• Hands-on experience with QC instruments and related data systems; strong troubleshooting skills.

Responsibilities

• Provide site-level leadership for the Laboratory Information Management System (LIMS).
• Develop and execute implementation roadmaps, resource plans, schedules, and budgets; monitor progress and risks.
• Embed data integrity across the system lifecycle from requirements to routine use.
• Gather and document user requirements; define process standards to improve efficiency.
• Author, validate, and maintain SOPs, test scripts, and training materials.
• Configure, maintain, and upgrade LIMS to align with change control.
• Design master data templates and controlled vocabulary.
• Supervise day-to-day workload of a small team; remove roadblocks and ensure on-time delivery.
• Coach and develop team members; provide feedback and growth opportunities.
• Monitor system performance, log defects, and drive continuous improvements.
• Incorporate GMP/23 CFR 11 and EU Annex 11 compliance into system design and operations.
• Prepare and deliver status updates to leadership, auditors, and stakeholders.

Skills

Leadership

Communication

Cross-functional teamwork

Coaching/mentoring

Decision making

Project management

Change management

Education

Bachelor's degree in Life Sciences or equivalent

Master's degree in Life Sciences (Biology or Microbiology)

Tools

LIMS

Smartsheet

SAP

LabWare v8

Job description

Position Overview

The Supervisor, QC Laboratory Information Management System (LIMS) provides frontline leadership to implement, maintain, and continuously improve the global Laboratory Information Management System in Quality Control. This role translates global and site requirements into configuration, validation, and rollout plans, harmonizes processes across current and future sites per established standards, and drives the QC transition to a paperless environment. The Supervisor leads a small team of LIMS specialists/analysts, serves as a site-level subject matter expert, and ensures the system is reliable, compliant, and aligned with operational needs.

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 coordination as a site-level subject matter expert and recognized contributor for the Laboratory Information Management System.
• Supports the development and execution of implementation roadmaps, resource plans, schedules, and budget tracking; monitors progress, risks, and mitigations and reports status to management.
• Embeds data integrity principles into all phases of the system lifecycle, from requirements and design through validation, release, and routine use.
• Leads or co-leads activities to:
• Gather and document user requirements; define process standards and best practices that improve laboratory operations, reduce cycle time, and increase efficiency.
• Identify and assess opportunities to streamline implementation and change management processes.
• Author, execute, and maintain validation protocols, Standard Operating Procedures, test scripts, job aids, and training materials.
• Configure, customize, maintain, and upgrade the Laboratory Information Management System in alignment with change control requirements.
• Design and maintain master data templates and controlled vocabulary.
• Supervises and prioritizes the day-to-day workload for a small team; assign tasks, remove roadblocks, and ensure on-time, right-first-time delivery.
• Coaches, trains, and supports team members; provides constructive feedback and fosters professional growth.
• Monitors system performance and user feedback; logs defects, coordinates remediation, and implements approved continuous improvements.
• Integrates quality and regulatory compliance requirements into system design, documentation, and routine operations (e.g., Good Manufacturing Practice, Good Documentation Practice, 21 Code of Federal Regulations Part 11, European Union Annex 11).
• Prepares and delivers clear presentations, demonstrations, and status updates to leadership, auditors, clients, and other stakeholders.
• Performs administrative responsibilities (e.g., timecard reviews/approvals, time-off requests, expense submissions) accurately and on time.
• Participates in recruiting, onboarding, and retention efforts in partnership with management and Human Resources.
• Addresses routine performance or conduct issues; responds to employee questions and partners with Human Resources and management for escalations or formal actions.
• Performs other related duties as assigned.

Knowledge, Skills, and Abilities

• Demonstrated leadership, technical aptitude, and problem-solving skills.
• Excellent verbal and written communication skills to comfortably and clearly articulate issues with peers and colleagues at all levels in the organization.
• Demonstrated capability in a cross-functional team environment, working cooperatively with others in effective ways that attain goals while encouraging teamwork and synergies throughout the organization.
• Demonstrated capability in coaching and development of personnel.
• Able to make informed and timely decisions independently.
• Leadership traits that build and foster trust, respect, cooperation, and collaboration across the organization.
• Strong team skills, including ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict.
• Must be goal-oriented and able to manage risks.
• Ability to coach, lead, and develop individual contributors.
• Ability to effectively present information to others.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• Bachelors in Life Sciences (Biology or Microbiology) with 4+ years of relevant experience; OR,
• Masters in Life Sciences (Biology or Microbiology) with 2+ years of relevant experience.
• Proven ability to lead teams.
• Experience working in a regulated GMP environment.
• Prior Hands-on experience with common QC instruments and associated data systems; strong troubleshooting skills.

Preferred Qualifications

• Experience leading teams in a laboratory setting.
• Experience and advanced understanding of large-scale biomanufacturing processes.
• Experience in leading startup activities and program-forming initiatives, e.g., creation of systems or business processes that support Quality objectives.
• Experience with Microsoft Office, Smartsheet and laboratory LIMS.
• and ERP systems (e.g., SAP).
• Experience in LabWare v8.

Physical Requirements:

• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
• Will work in environment operating a motor vehicle or Powered Industrial Truck.
• Ability to discern audile cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time for up to 60 minutes.
• Ability to sit for prolonged periods of time for up to 60 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18'' to 60'' in height, and use twisting motions.

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 ([e-mail]).