Global GLP Vendor Quality Lead

CSL Plasma Inc.; Maidenhead; On-site; GBP 60,000 - 90,000; Full time

Job summary

CSL Plasma Inc. is seeking a GLP Vendor Oversight and QA Lead to safeguard nonclinical data integrity across external laboratories and CROs.

You will be the internal authority on GLP, GCP, GMP, and data integrity, leading vendor qualification, quality agreements, risk-based monitoring, and CAPA processes. You will collaborate with Nonclinical Development, Procurement, Legal and IT to embed quality requirements in scopes of work, manage audits and inspections, and drive continuous improvement

Qualifications

• Bachelor's degree in a relevant scientific discipline.
• 3+ years of GxP quality experience with direct vendor/CRO oversight and/or auditing.
• Knowledge of OECD GLP, 21 CFR Part 58, Annex 11/Part 11 and data integrity (ALCOA+).
• Strong communication and negotiation skills.

Responsibilities

• Own quality oversight of external partners supporting nonclinical and GLP activities (CROs, laboratories, test facilities).
• Lead the vendor lifecycle: due diligence, qualification, quality agreements, risk-based monitoring, issue management and CAPA closure.
• Identify and prioritise vendors for audit; plan, conduct and grade inspections; verify CAPA effectiveness.
• Embed quality requirements in scopes of work and contracts; guide technology transfers and data flows.
• Embed quality requirements in scopes of work and contracts; train stakeholders.
• Stay current with GLP and GxP regulations and CSL requirements.

Skills

Vendor oversight

GxP quality

Auditing

Regulatory knowledge

Communication

Problem solving

Education

Bachelor's degree in a relevant scientific discipline

Tools

QMS software

Job description

CSL Plasma Inc. is seeking a GLP Vendor Oversight and QA Lead to safeguard nonclinical data integrity across external laboratories and CROs.

You will be the internal authority on GLP, GCP, GMP, and data integrity, leading vendor qualification, quality agreements, risk-based monitoring, and CAPA processes. You will collaborate with Nonclinical Development, Procurement, Legal and IT to embed quality requirements in scopes of work, manage audits and inspections, and drive continuous improvement