GLP Vendor Oversight and Quality Assurance Lead

CSL Behring is a global biotherapeutics leader dedicated to saving lives through innovative therapies. With a focus on addressing unmet medical needs, CSL Behring develops and delivers breakthrough treatments for patients suffering from conditions in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. The company employs advanced scientific platforms including plasma fractionation, recombinant protein technology, and cell and gene therapy, which facilitate continual innovation and the enhancement of product efficacy and safety. Operating one of the world’s largest plasma collection networks, CSL Plasma, it is a vital part of CSL, a global company headquartered in Melbourne, Australia, employing over 32,000 people and supplying lifesaving therapies to more than 100 countries worldwide.

The role of Vendor Lifecycle and Governance Specialist at CSL Behring is a critical quality assurance position focusing on external partner oversight in nonclinical and Good Laboratory Practice (GLP) activities. This role encompasses the management of vendor relationships including Contract Research Organizations (CROs), laboratories, and test facilities ensuring compliance with GLP, Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP). The incumbent will lead the vendor lifecycle processes from due diligence, qualification, and contract negotiation of quality agreements to risk-based monitoring, issue management, and driving continuous quality improvements. The position demands collaboration with cross-functional teams such as Nonclinical Development, Procurement, Legal, and IT to embed regulatory and quality requirements in all vendor interactions.

Key responsibilities include conducting risk-based vendor qualifications and requalification, drafting and maintaining quality agreements, establishing vendor Key Performance Indicators (KPIs), facilitating governance forums, and ensuring corrective and preventive actions (CAPAs) are addressed and closed effectively. The role also involves prioritization and planning of vendor audits, coordinating inspection readiness activities, and ensuring compliance with global regulations such as OECD GLP principles, 21 CFR Part 58, ICH guidelines, ISO standards, and ALCOA+ data integrity principles. The specialist will lead vendor risk assessments using tools like risk registers and Failure Mode and Effects Analysis (FMEA) to determine oversight frequencies, identify improvement opportunities, and present trend analyses in management reviews.

Strong competencies required include the ability to work independently and across multinational teams, excellent analytical and problem-solving skills, and demonstrated expertise in quality management system implementation and regulatory frameworks. This role requires effective interpersonal and communication skills to negotiate and influence partners and internal stakeholders. The candidate will also manage audit and inspection processes, provide training on quality requirements, and stay current on regulatory changes to continuously refine CSL Behring’s quality oversight procedures.

This opportunity includes up to 50% travel to support vendor audits, inspections, and partnership engagements globally. CSL Behring offers a supportive and inclusive work environment where diversity and belonging are integral to organizational success. The company values innovation and continuous improvement to make a meaningful impact on patient lives worldwide.