Supervisor, Quality Control LIMS

Fujifilm • Holly Springs, NC

1d • Onsite

About The Position

Lead the reliability and data integrity of a modern quality control laboratory. As our QC Instrumentation & LIMS Supervisor, you will ensure instruments and systems run flawlessly, embed compliance into every step of the lifecycle, and guide a capable team to deliver right-first-time results that accelerate safe, effective biomanufacturing. 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. We are a collaborative, patient-focused biologics organization committed to quality, integrity, and continuous improvement. Our teams operate in a fast-paced, GMP-regulated environment where cross-functional partnership and operational excellence enable us to deliver for patients and partners. You will serve as a site-level subject matter expert for laboratory instrumentation and the Laboratory Information Management System—bringing together people, process, and technology to elevate performance and compliance. Inclusive culture that values diverse perspectives, safety, and data integrity (ALCOA+) Strong partnership across Quality Control, Manufacturing, MSAT, Facilities, and IT Focus on scalable systems, sustainable compliance, and continuous improvement.

Requirements

• 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

Nice To Haves

• 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 working in a contract manufacturing or testing organization
• Experience managing vendor service contracts, IOQ, and lifecycle management for instruments

Responsibilities

• Supervise daily QC instrumentation activities in alignment with approved procedures
• Draft, route, and implement change controls, deviations, and related records
• Schedule and execute instrumentation maintenance and qualification activities (PMs, calibrations, IOQ/PQ, periodic reviews)
• Adjust priorities to meet production needs; communicate workload changes to stakeholders
• Ensure equipment readiness and data integrity, including: Instrument logbook control, audit trail review, backup/restore processes, access management
• Adherence to ALCOA+ principles and data governance standards
• Plan and execute Analytical Instrumentation Qualification (AIQ) for instrument software and data systems (e.g., CDS, LIMS connections), including: User requirement specifications (URS), risk assessments, test execution, and change management
• Alignment with 21 CFR Part 11, EU Annex 11, and site procedures
• Maintain QC systems and business processes within defined procedures (e.g., LIMS, CDS, CMMS, EMS/BMS, equipment logs, asset registry, spare parts inventory)
• Monitor system performance; initiate and lead issue resolution
• Lead troubleshooting for routine instrument and software issues; coordinate vendor support, service contracts, and escalations
• Ensure timely closure of service tickets and complete, accurate documentation
• Track and report instrumentation KPIs (e.g., equipment uptime, PM/calibration adherence, deviation/CAPA cycle time, service turnaround)
• Identify trends, implement approved corrective actions, and escalate risks or barriers to the Manager as needed
• Coordinate and deliver training for QC Instrumentation staff; verify training records are current
• Reinforce cGMP, data integrity, safety practices, and Good Documentation Practices
• Support internal and external inspections by maintaining complete and accurate records; assist with tours, provide documents, demonstrate systems, and respond to queries
• Perform administrative responsibilities (e.g., timecard reviews/approvals, time-off requests, expense submissions) accurately and on time
• Participate in recruiting activities (e.g., resume review, interviews) and support retention initiatives with the Manager and HR
• Address routine performance or conduct issues; respond to employee questions; partner with HR and the Manager for escalations or formal actions
• Coach and guide direct reports to foster professional development
• Provide cross-functional coordination as a site-level subject matter expert and recognized contributor for the Laboratory Information Management System (LIMS)
• Support development and execution of implementation roadmaps, resource plans, schedules, and budget tracking; monitor progress, risks, mitigations, and report status to management
• Embed data integrity principles into all phases of the system lifecycle—from requirements and design through validation, release, and routine use
• Lead or co-lead 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, SOPs, test scripts, job aids, and training materials
• Configure, customize, maintain, and upgrade LIMS in alignment with change control requirements
• Design and maintain master data templates and controlled vocabulary
• Supervise and prioritize the day-to-day workload for a small team; assign tasks, remove roadblocks, and ensure on-time, right-first-time delivery
• Coach, train, and support team members; provide constructive feedback and foster professional growth
• Monitor system performance and user feedback; log defects, coordinate remediation, and implement approved continuous improvements
• Integrate quality and regulatory compliance requirements into system design, documentation, and routine operations (e.g., GMP, GDP, 21 CFR Part 11, EU Annex 11)
• Prepare and deliver clear presentations, demonstrations, and status updates to leadership, auditors, clients, and other stakeholders
• Perform administrative responsibilities (e.g., timecard reviews/approvals, time-off requests, expense submissions) accurately and on time
• Participate in recruiting, onboarding, and retention efforts in partnership with management and HR
• Address routine performance or conduct issues; respond to employee questions; partner with HR and management for escalations or formal actions
• Other duties, as assigned

Benefits

• Equitable, competitive compensation with performance recognition
• Comprehensive health, dental, and vision coverage
• Retirement savings plan with employer contribution
• Paid time off, holidays, and leave programs
• Learning and development opportunities, including validation, data integrity, and leadership training
• Flexible work practices where role-appropriate
• Meaningful impact in a GMP environment with opportunities to drive system improvements and shape best practices
• Inclusive workplace with reasonable accommodations available throughout the hiring process

What This Job Offers

• Job Type: Full-time
• Career Level: Manager