Global LIMS & Quality Systems Lead

CSL Plasma; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

CSL Plasma is seeking a quality systems specialist to support the Laboratory Information Management System (LIMS) global oversight. You will participate in validation, deviation investigations, CAPA administration, and change controls to ensure cGMP compliance across sites.

The role requires a bachelor’s degree in a relevant field and 4–8 years of laboratory experience with quality systems experience in pharma manufacturing. Onsite work and global collaboration are essential.

Qualifications

• Bachelor degree in Engineering, Business or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.)
• 4-8 years of laboratory experience
• 3-5 years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environment
• Experience with electronic management systems for documents, specifically LIMs preferred.
• Refer to local job documentation where applicable.

Responsibilities

• Supports development and maintenance of global quality system processes for LIMS oversight.
• Provides LIMS technical support ensuring cGMP compliance and regulatory requirements.
• Acts as global SME to support the Global LIMS System and manage GLIMS processes.
• Participates in deviations investigations and CAPA related to systems.
• Leads testing, validation, and change management activities for LIMS.
• Interfaces with local and global developers to improve system functionality.

Skills

Laboratory experience

Quality systems

cGMP compliance

LIMS knowledge

Data analysis

Education

Bachelor degree in Engineering, Business or a relevant scientific discipline

Tools

LIMS software

Job description

CSL Plasma is seeking a quality systems specialist to support the Laboratory Information Management System (LIMS) global oversight. You will participate in validation, deviation investigations, CAPA administration, and change controls to ensure cGMP compliance across sites.

The role requires a bachelor’s degree in a relevant field and 4–8 years of laboratory experience with quality systems experience in pharma manufacturing. Onsite work and global collaboration are essential.