GLP Vendor Quality Lead | Oversight & Audits

CSL; King of Prussia (PA); On-site; USD 120,000 - 180,000; Full time

Job summary

CSL is seeking a GLP Vendor Oversight and QA Lead in King of Prussia, PA to own external partner quality programs. You will drive risk-based oversight, audits, and continuous improvement across CROs and laboratories to ensure GLP, GCP, GMP compliance and data integrity.

Responsibilities include establishing Quality Agreements, KPIs, audit readiness, and collaboration with Nonclinical Development, Legal and IT to embed quality into contracts and transfers.

Qualifications

• 3+ years of GxP quality experience with direct vendor/CRO oversight or auditing.
• Knowledge of OECD GLP, 21 CFR Part 58, and ALCOA+ data integrity.
• Strong communication and negotiation skills.

Responsibilities

• Oversee external partners in nonclinical/GLP activities and ensure GLP/GCP/GMP compliance.
• Lead vendor lifecycle activities: due diligence, qualification, quality agreements, risk-based monitoring, CAPA.
• Develop and monitor KPIs, governance forums, and CAPA closure.
• Coordinate inspections readiness and support for audits.
• Embed quality requirements in scopes of work and contracts; train stakeholders.
• Maintain up-to-date knowledge of regulatory requirements and CSL standards.

Skills

Vendor oversight

Quality assurance

Regulatory knowledge

Auditing

Data integrity ALCOA+

GxP knowledge

Communication

Negotiation

Cross-functional collaboration

Education

Bachelor's degree in a relevant scientific discipline

Job description

CSL is seeking a GLP Vendor Oversight and QA Lead in King of Prussia, PA to own external partner quality programs. You will drive risk-based oversight, audits, and continuous improvement across CROs and laboratories to ensure GLP, GCP, GMP compliance and data integrity.

Responsibilities include establishing Quality Agreements, KPIs, audit readiness, and collaboration with Nonclinical Development, Legal and IT to embed quality into contracts and transfers.