Supervisor, Quality Control LIMS

Fujifilm•Holly Springs, NC

7d•Onsite

About The Position

The Supervisor, Quality Control 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 according to established standards; and drives the QC transition to a paperless environment. The Supervisor leads a small team of LIMS specialists or analysts, serves as a site-level subject matter expert, and ensures the system is reliable, compliant, and aligned with operational needs. The role coordinates across functions and supports implementation roadmaps, resource plans, schedules, and budget tracking. It embeds data-integrity principles across the system lifecycle, from requirements and design through validation, release, and routine use. The Supervisor leads or co-leads requirements gathering, process-standard development, system configuration and maintenance, validation documentation, master-data management, and continuous improvement. The position also manages daily team workloads and development, supports hiring and employee matters, and communicates with leadership, auditors, clients, and other stakeholders. FUJIFILM Biotechnologies is developing a biopharmaceutical manufacturing facility in Holly Springs, North Carolina, with drug substance production, fill-finish, and packaging. The company describes its culture as Genki and is guided by the Group Purpose of “giving our world more smiles.” The role must be flexible to support a 24/7 manufacturing facility.

Requirements

Bachelor’s degree in Life Sciences (Biology or Microbiology) and at least 4 years of relevant experience, or a master’s degree in Life Sciences (Biology or Microbiology) and at least 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 articulate issues clearly with peers and colleagues at all organizational levels.
Ability to work cooperatively in cross-functional teams and encourage teamwork and organizational collaboration.
Demonstrated capability in coaching and developing personnel.
Ability to make informed and timely decisions independently.
Ability to build and foster trust, respect, cooperation, and collaboration across the organization.
Strong team skills, including coaching and developing work teams, providing training, motivating and empowering others, and resolving conflict.
Goal-oriented approach and ability to manage risks.
Ability to coach, lead, and develop individual contributors.
Ability to present information effectively.
Flexibility to support a 24/7 manufacturing facility.

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

Coordinate cross-functionally 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 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 LIMS in alignment with change-control requirements.
Design and maintain master-data templates and controlled vocabulary.
Supervise and prioritize day-to-day workload for a small team, assign tasks, remove roadblocks, and ensure on-time, right-first-time delivery.
Coach, train, support, and provide constructive feedback to team members while fostering 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, including GMP, GDP, 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.