Global LIMS Quality Lead & Compliance Expert

CSL; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

CSL is seeking a GLIMS-focused Quality Systems Specialist to support the global LIMS program, ensuring cGMP compliance and data integrity across laboratory processes. You will act as a global SME, drive system changes, and coordinate cross-functional teams across manufacturing, development and QA.

The role includes validation, testing, and change control activities, plus collaboration with local and global stakeholders to optimize laboratory quality systems and drive CAPA resolutions.

Qualifications

• Bachelor degree in Engineering, Business or relevant scientific discipline.
• 4-8 years laboratory experience.
• 3-5 years quality systems experience in pharma/cGMP environment.
• Experience with electronic management systems for documents, specifically LIMS.

Responsibilities

• Administer GLIMS changes and provide SME guidance.
• Ensure compliance with policies, legal and regulatory requirements.
• Support deviation investigations and CAPA closure.
• Lead testing, validation, and UAT for GLIMS processes.
• Interface with global developers to improve system functionality.
• Lead project delivery and support Change Management activities.
• Participate in training and vendor/audit readiness related to GLIMS.

Skills

LIMS knowledge

Quality systems

cGMP compliance

Data analysis

Project coordination

Education

Bachelor degree in Engineering/Science

Tools

LIMS (GLIMS)

Electronic document management systems

Job description

CSL is seeking a GLIMS-focused Quality Systems Specialist to support the global LIMS program, ensuring cGMP compliance and data integrity across laboratory processes. You will act as a global SME, drive system changes, and coordinate cross-functional teams across manufacturing, development and QA.

The role includes validation, testing, and change control activities, plus collaboration with local and global stakeholders to optimize laboratory quality systems and drive CAPA resolutions.