GLP Vendor Oversight and QA Lead

CSL Plasma; King of Prussia (PA); On-site; USD 120,000 - 160,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

GxP quality experience

Vendor/CRO oversight

Communication skills

Negotiation skills

Analytical skills

Problem-solving

Organisational skills

Education

Bachelor's degree in a scientific discipline

Job description

GLP Vendor Oversight and QA Lead

The integrity of nonclinical data depends on more than what happens inside a company's walls. Much of the critical work in GLP-regulated research - safety studies, toxicology, analytical testing - is carried out by external laboratories and CROs. When that network of partners operates to the highest quality standards, the science is sound. When it doesn't, the consequences reach all the way to patients. This role exists to make sure it works.

Why this role matters

GLP vendor oversight is often invisible when it's done well - and very visible when it isn't. As the internal authority on GLP and nonclinical vendor quality, you will be the person others turn to when the questions are difficult. If you take data integrity seriously, understand the regulatory landscape deeply, and want to shape how a global company manages its external nonclinical network, this is a role with real scope to make a difference.

About the role

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 continuous improvement, ensuring adherence to GLP/GCP/GMP, data integrity and applicable regulations. Partner with Nonclinical Development, Procurement, Legal and IT.

Vendor Lifecycle and Governance: Run risk-based qualification and requalification, draft and maintain Quality Agreements, and set vendor KPIs and governance forums, ensuring actions and CAPAs are closed.

Inspections: Identify and prioritise vendors for audit on a risk basis; planning, conducting and grading sits with the audit function. Confirm vendor CAPAs are fit for purpose and run effectiveness checks. Coordinate inspection readiness and front- and back-room support.

Quality Systems and Compliance: Ensure vendor practices meet GLP/GCP/GMP, OECD GLP, 21 CFR Part 58, ICH, ISO and data integrity (ALCOA+). Provide input on third-party deviations, change control, CAPA, and the QMS.

Risk Management and Continuous Improvement: Lead vendor risk assessments (risk registers, FMEA) to set oversight frequency, improve vendor performance, and present trends at management reviews.

Cross-Functional Partnership: Embed quality requirements in scopes of work and contracts, guide technology transfers and data flows, and train internal stakeholders.

Maintain and share knowledge of Regulations and Requirements: Stay current with GLP and GxP regulations and translate changes into CSL requirements.

Position Qualifications and Experience Requirements

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

Competencies

• Works with limited supervision across multinational teams.
• Strong analytical, problem-solving, influencing and organisational skills.
• Knowledge of QMS implementation, regulatory frameworks and audit/inspection management.