Supervisor, Quality Control LIMS

Fujifilm•Holly Springs, NC

About The Position

The Supervisor, QC Laboratory Information Management System (LIMS) provides frontline leadership to implement, maintain, and continuously improve the global LIMS in Quality Control. The role translates global and site requirements into configuration, validation, and rollout plans, harmonizes processes across current and future sites in accordance with established standards, and drives the QC transition to a paperless environment. The Supervisor leads a small team of LIMS specialists or analysts, acts as a site-level subject matter expert, and ensures the system is reliable, compliant, and aligned with operational needs. The position coordinates across functions and supports implementation roadmaps, resource plans, schedules, and budget tracking. It embeds data integrity and quality and regulatory requirements throughout the system lifecycle, from requirements and design through validation, release, and routine use. The Supervisor oversees system configuration and maintenance, controlled documentation, master data, troubleshooting, defect remediation, and continuous improvement, while managing and developing team members. The role also communicates system status to leadership, auditors, clients, and other stakeholders and performs associated supervisory and administrative duties. FUJIFILM Biotechnologies is developing a biopharmaceutical manufacturing facility in Holly Springs, North Carolina, with drug substance production, fill-finish, and packaging. The company describes a dynamic work environment and a culture called Genki.

Requirements

Bachelor's degree in Life Sciences (Biology or Microbiology) and 4+ years of relevant experience, or a master's degree in Life Sciences (Biology or Microbiology) and 2+ years of relevant experience.
Proven ability to lead teams.
Experience working in a regulated GMP environment.
Hands-on experience with common QC instruments and associated data systems, with strong troubleshooting skills.
Demonstrated leadership, technical aptitude, and problem-solving skills.
Excellent verbal and written communication skills, including the ability to clearly articulate issues to peers and colleagues at all organizational levels.
Ability to work cooperatively in cross-functional teams to attain goals and encourage teamwork and synergies.
Capability in coaching and developing personnel and work teams, providing training, motivating and empowering others, and resolving conflict.
Ability to make informed and timely decisions independently.
Ability to build and foster trust, respect, cooperation, and collaboration across the organization.
Goal-oriented approach and ability to manage risks.
Ability to effectively present information to others.
Flexibility to support a 24/7 manufacturing facility.
Ability to meet the stated physical requirements, including standing and sitting for prolonged periods up to 60 minutes, repetitive hand and wrist motions, moving objects up to 10 pounds, bending, pushing or pulling, reaching, and twisting.
Ability to discern audible cues and perform visual tasks with 20/20 corrected vision, including distinguishing colors.

Nice To Haves

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

Responsibilities

Provide cross-functional coordination as a site-level LIMS subject matter expert and recognized contributor.
Support development and execution of implementation roadmaps, resource plans, schedules, and budget tracking; monitor progress, risks, and mitigations and report status to management.
Embed data integrity principles throughout the system lifecycle, from requirements and design through validation, release, and routine use.
Gather and document user requirements and define process standards and best practices to 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 LIMS in alignment with change control requirements.
Design and maintain master data templates and controlled vocabulary.
Supervise and prioritize the day-to-day workload of 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 requirements into system design, documentation, and routine operations, including GMP, Good Documentation Practice, 21 CFR Part 11, and EU Annex 11.
Prepare and deliver presentations, demonstrations, and status updates to leadership, auditors, clients, and other stakeholders.
Complete administrative responsibilities such as timecard reviews and approvals, time-off requests, and expense submissions accurately and on time.
Participate in recruiting, onboarding, and retention efforts with management and Human Resources.
Address routine performance or conduct issues, respond to employee questions, and partner with Human Resources and management on escalations or formal actions.
Perform other related duties as assigned.