CQA Vendor Oversight and Quality Assurance Lead (US)

CSL Behring is a global biotherapeutics leader committed to saving lives by delivering innovative therapies for people with conditions in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Rooted in cutting-edge science, CSL Behring uses scientific platforms such as plasma fractionation, recombinant protein technology, and cell and gene therapy to pioneer new solutions that meet unmet medical needs. Headquartered in Melbourne, Australia, and operating one of the world's largest plasma collection networks, CSL Plasma, the company employs over 32,000 colleagues and delivers advanced therapies to more than 100 countries worldwide.

The role of CQA Vendor Oversight and Quality Assurance Lead is pivotal within the organization, providing comprehensive quality oversight of external partners supporting research and development as well as regulated activities. This includes Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), laboratories, and technology vendors. The position encompasses leadership over the entire vendor lifecycle process, from due diligence and qualification through to quality agreements, risk-based monitoring, issue management, and continuous improvement initiatives.

This role ensures strict adherence to global standards such as Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Pharmacovigilance Practice (GVP), along with data integrity principles and relevant regulations. Close collaboration with cross-functional teams including Clinical, Nonclinical, Chemistry Manufacturing and Controls (CMC), Safety, Procurement, Legal, and Information Technology is required to ensure vendors deliver compliant, reliable services that meet strict quality requirements. The lead manages vendor performance using KPIs, service level agreements (SLAs), and quality dashboards, guiding corrective and preventive actions (CAPAs) to maintain a healthy and productive relationship.

Key responsibilities include defining and executing vendor qualification strategies, contributing to quality agreement development, supporting audit planning and execution, managing inspection readiness, ensuring adherence to quality management systems, driving risk assessments, and continuously identifying improvement opportunities. The role also emphasizes training internal stakeholders on third-party quality expectations, maintaining up-to-date knowledge on GxP regulations, and serving as a quality resource across CSL-specific vendor operations.

Candidates for this role should have a bachelor's degree in a relevant scientific discipline and possess at least three years of experience managing GxP quality oversight or audits of external vendors. Expertise in regulatory frameworks such as ICH guidelines, FDA and EMA standards, and data integrity principles are critical. Effective communication, negotiation skills, and the ability to work with multinational teams and external suppliers are essential competencies. This position may require up to 50% travel to vendor sites globally.

CSL Behring offers a dynamic environment that fosters innovation, inclusion, and belonging, with a diverse workforce dedicated to transforming patient care. Employees benefit from a comprehensive package designed to support their well-being and professional growth, making CSL a leading destination for top talent in the biotherapeutics industry.