Auditor - GLP

Job Responsibilities Support execution of global RDQ audit plans to assess the accuracy and quality of scientific data and/or ensure compliance with relevant guidelines, legal requirements, relevant 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, ECs/IRBs. Perform self‑inspections/audits of internal processes/procedures relevant to assigned GxP, including but not limited to PV process/procedure, Local and Regional Safety Officers (LSO/RSOs), clinical E‑Systems, databases. Develop, review, and issue Audit Reports outlining findings categorized according to level of risk(s) and 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, 3rd party vendors and interfacing functions. Escalate non‑compliances and communicate trends to line management, RDQ LT and relevant GxP functional leads. Support continuous improvement initiatives focusing on processes, procedures, and SOPs for conducting and documenting audits and inspections outcome communications. Partner with stakeholders to assist in developing and communicating innovative, compliant solutions using a risk‑based approach for internal and external inspections with recommended solutions. Support development of improved principles of auditing and inspections. Ensure accreditation, qualification to perform required inspections and adherence to processes and SOPs to ensure 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 internally. Qualifications BS degree in a relevant biological science, science, or related discipline. 3+ years of Quality Assurance experience within a GVP or GCP environment (other GxP environments will be 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 skills, and excellent organizational skills with respect to planning, tracking, and timelines. Demonstrated knowledge of QMS implementation and regulatory frameworks. Strong understanding of the requirements for Quality Assurance in a relevant GxP discipline. Experience in audit/inspection management and processes. 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 CSL