GLP Vendor QA & Compliance Leader

CSL Plasma; King of Prussia (PA); Sur place; USD 120 000 - 160 000; Plein temps

Résumé du poste

CSL Plasma seeks a GLP Vendor Oversight and QA Lead to ensure external partners meet GLP, GxP, and data integrity standards across nonclinical activities. You will own vendor governance, risk assessment, and continuous improvement with CROs and labs.

The role partners with Nonclinical Development, Procurement, Legal, and IT to embed quality requirements in contracts, scopes of work, and data flows, while leading audits and CAPA closures.

Qualifications

• GxP quality experience with direct vendor/CRO oversight (GLP/GCP/GMP).
• Knowledge of OECD GLP, 21 CFR Part 58, Part 11 and data integrity.
• Strong communication, negotiation, analytical and organizational skills.

Responsabilités

• Oversee the vendor lifecycle including due diligence, qualification, and KPIs.
• Lead risk-based monitoring, CAPAs, and continuous improvement with CROs.
• Coordinate audits, inspections readiness, and vendor CAPA closure.
• Ensure GLP/GCP/GMP compliance and data integrity across external partners.
• Collaborate with Nonclinical Development, Procurement, Legal and IT.
• Maintain CSL requirements and translate regulatory changes into practice.

Connaissances

GxP quality experience

Vendor/CRO oversight

Communication skills

Negotiation skills

Analytical skills

Problem-solving

Organisational skills

Formation

Bachelor's degree in a scientific discipline

Description du poste

CSL Plasma seeks a GLP Vendor Oversight and QA Lead to ensure external partners meet GLP, GxP, and data integrity standards across nonclinical activities. You will own vendor governance, risk assessment, and continuous improvement with CROs and labs.

The role partners with Nonclinical Development, Procurement, Legal, and IT to embed quality requirements in contracts, scopes of work, and data flows, while leading audits and CAPA closures.