Auditor - GLP

The Role Support execution of global RDQ audit plans to assess the accuracy and quality of scientific data and ensure compliance with relevant guidelines, legal requirements, GxPs, and CSL Corporate requirements. Assist in the development of a global audit program and schedule, in collaboration with RDQ and functional stakeholders. Perform external audits of clinical investigator sites, E‑Systems, databases, contract CROs/vendors, and ECs/IRBs. Perform self‑inspections/audits of internal processes and procedures relevant to assigned GxP, including but not limited to PV processes/procedures, Local and Regional Safety Officers (LSO/RSOs), clinical E‑Systems, and databases. Develop, review, and issue Audit Reports outlining findings, categorized according to level of risk, and providing corrective and preventive actions (CAPA) recommendations. Identify non‑compliance trends and systematic risks for assigned GxP. Analyze audit observations, gaps, and systematic issues to support continuous improvement within the assigned GxP discipline, affiliates, third‑party vendors, and interfacing functions. Escalate non‑compliances, communicating trends to line management, RDQ LT, and relevant GxP functional leads. Support continuous improvement initiatives focusing on processes, procedures, and standard operating procedures (SOPs) for conducting and documenting audits and inspection outcome communications. Partner with stakeholders to develop and communicate innovative, compliant solutions using a risk‑based approach for internal and external inspections, recommending solutions. Support development of improved principles of auditing and inspections. Ensure the upkeep of accreditation and qualification to perform required inspections and adhere to processes and SOPs so that inspectors are trained and accredited. Maintain and share knowledge of regulations and requirements. Stay current and up to date with GxP regulations and requirements related to audit management as well as industry/regulatory trends in this area. Identify and/or create new requirements to ensure a high level of quality and communicate them internally. Skills & Experience BS degree in a relevant biological science, science, or related discipline. 3+ years of Quality Assurance experience within a GVP, GCP environment (other GxP environments considered). Ability to work with limited supervision and with multinational teams and external suppliers speaking different languages. Strong analytical and problem‑solving skills, excellent interpersonal, communication, influencing, negotiation, and organizational skills regarding planning, tracking, and timelines. Demonstrated knowledge of QMS implementation and regulatory frameworks. A strong understanding of the requirements for Quality Assurance in relevant GxP discipline. Experience in audit/inspection management and processes. Travel: 50% travel across the Americas (North, Central and South America). Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit #J-18808-Ljbffr BioSpace