Head, Clinical Trial QA

The Opportunity:

• The Head of Clinical Trial Quality Assurance role maintain and enhance the Global Clinical Trial Quality System supporting Early to Late-stage clinical development projects within R&D, utilizing and improving the existing R&D Quality Management System in alignment with CSL overarching Quality Management System administered and managed by Global Quality.

• This position strategically oversees aspects of the R&D Quality Management in relation to key quality elements such as Document Management, Knowledge Management, Significant Issue / Serious Breach Management, Deviation and CAPA Management, Risk Management, Continuous Improvement, Inspection Management, Change Management and R&D Quality Governance associated with R&D clinical development.

• The role manages a Global Clinical quality department supporting early and late-stage clinical trials for all CSL business units across all R&D anchor sites.

• Develop and maintain an approach for inspection management related to clinical trials and the R&D QMS, focused on preparing CSLB for Sponsor Monitor inspections that will focus on R&D development programs.

• The Head of Clinical Trial Quality Assurance is a key leadership position for providing strategic direction and managerial oversight as the global footprint of CSLB expands. This is especially relevant as CSLB enters new emerging growth markets where integration and alignment with the global R&D Quality Management System is business critical.

The Role:

• Direct, manage, and strategically improve clinical quality assurance (CQA) function globally. Ensuring best use of capabilities, expertise, and harmonized processes/procedures within Global CQA to enable consistent implementation of standards, integrity of processes, structures and systems on a global scale, including emerging markets

• Provide high quality GCP and cross functional consultancy expertise to guide the R&D organization and leadership in maintaining required compliance

• Provide GCP and process related guidance and support 

• Works with teams/ senior management to investigate and resolve non-compliance, deviations and process related issues providing recommendations for solutions and CAPAs as needed

• Ensure continuous assessment of key quality/performance indicators across entire pre-clinical and clinical system 

• Ensure the provision of accurate and timely reports on pre-clinical/clinical development metrics, findings, and trends stemming from audits, inspections and deviations and proposes and/or implements improvement initiatives, as needed 

• Lead appropriate governance meetings and ensure adequate attendance of CQA staff to relevant meetings globally where CQA input is required, e.g. compliance monitoring/ signals, and other governance bodies

• Ensure analysis and reporting of audit observations, gaps and systematic issues to relevant CSL management functions to improve processes within Pre-Clinical/ Clinical Development as well as affiliates, 3rd party vendors and interfacing functions.  

• Evaluate adequacy and completeness of CAPAs originating from audits, deviations and/or inspections. Including communication and presentation of summaries of audit findings, trends, KPIs with recommendations to drive significant continuous improvement activities

• Ensure timely reporting of serious GxP breaches to Regulatory Authorities, as required.  

• Develop and oversee a GxP appropriate significant quality issues management procedure

• Provide leadership and guidance in the preparation, conduct and response preparation relating to health authority inspections and 3rd party audits

• Direct/lead preparation activities for inspections and 3rd party audits; ensure preparation of inspection strategy plans and their timely implementation, lead/ direct mock inspections/ mock inspection activities

• Ensure adequate communication of results and inspection preparedness to appropriate customer groups/ upper/ executive management

• Act as primary Inspection Coordinator during inspections, including direct interaction with inspectors in preparation, during conduct and follow-up of inspection

• Support CSL affiliates with external CQA audits and inspections

• Globally direct and actively conduct for-cause activities and other complex compliance related investigations, as needed

• Support of GMP/ PV health au