The Opportunity:

• This role will be responsible for executing the global RDQ audit program within the specified GxP discipline to the accuracy and quality of scientific data, as well as compliance with relevant guidelines, legal requirements, GxPs, and CSL Corporate standards.

• The GxP auditor will conduct assigned audits, draft reports, and work collaboratively with the GxP compliance area QA staff to assure categorization, communication, and escalations of audit outcomes. 

• The program is primarily focused on external audits, and support for internal audits will be required occasionally. 

• As part of a broader audit team and Community of Practice this role will provide recommendations leading toward continuous improvements, enhancing audit skills, competence, and outputs.

The Role:

• 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.

• Development, review, and issue of Audit Reports outlining the 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 help to support continuous improvement within the assigned GxP discipline, as well as affiliates, 3rd 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 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 the upkeep accreditation, qualification to perform required inspections and adhere 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.

Skills & Experience:

• BS degree in relevant biological science, science, or related discipline

• 3+ years of Quality Assurance experience within a GVP, GCP environment, preferred (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 demonstrated 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.

• A strong understanding of the requirements for Quality Assurance in relevant GxP discipline.

• Experience in audit/inspection management and processes.