GLPGCLP Vendor Oversight and QA Lead (EU)

GLP Vendor Oversight and QA Lead

The integrity of nonclinical data depends on more than what happens inside a companys 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 doesnt 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 its done well and very visible when it isnt. 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:Bachelors 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.

About CSL Seqirus

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S. the U.K. and Australia CSL Seqirus utilizes egg cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

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Employment Type : Full-Time
Experience: years
Vacancy: 1