Director/Sr. Director, Clinical Quality

See Yourself at Telix

The Director/Senior Director, Clinical Quality will develop, manage, and improve existing quality systems to ensure appropriate controls for Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GLP) capabilities. This includes the expansion of the existing Clinical Quality Management System (QMS), development of documents, training of personnel, and quality oversight of clinical development. This position will be dedicated to supporting Telix's early and late-stage assets.

The Director/Senior Director, Clinical Quality will be responsible for Quality aspects of Clinical Research Organization (CRO) vendor oversight including audits, establishment of quality agreements, and major deviation review. This position will be responsible for or support BioResearch Monitoring Program (BIMO) inspection readiness, as well as Quality support of post approval pharmacovigilance systems. This role will work directly with the Clinical Operations, Development and Pharmacovigilance departments to provide continual oversight to enforce requirements and meet guidelines.

Key Accountabilities

• Lead and provide Quality strategy and oversight to ensure compliance with Good Clinical Practices (GCPs) Good Pharmacovigilance Practices (GPV), and Good Clinical Laboratory Practices (GLPs).
• Assure appropriate oversight of the Vendor Qualification Program, ensuring adequate vendor oversight and addressing any quality issues as needed for Clinical vendors.
• Drive audit preparation activities for regulatory GCP inspections and guide coordination of audit responses.
• Plan, arrange, and conduct external GCP audits at Investigator Sites, CROs, supporting laboratories, and monitoring organizations including writing audit reports and tracking resulting CAPAs.
• Review critical processes and procedures to identify gaps in standards, procedures and technologies that are a risk to clinical trial quality.
• Participate in initiatives related to critical quality processes such as essential document management, data management, trial management, investigational product management, etc.
• Partner with the Clinical Operations team to write, revise, and approve appropriate SOPs, Work Instructions and Forms
• Provide routine communication to leadership about the overall status of the Quality Management System specific to the Clinical side of business.
• Manage, develop, and build a high-performing Clinical Quality organization and its capabilities with a goal of supporting a quality-oriented approach company wide.
• Provide Quality oversight and compliance support for Clinical Development Teams.
• Develop and mentor the Quality staff in supporting GxP activities.

Education and Experience

• Bachelor's degree in Life Sciences or related discipline required; Master's degree preferred.
• 7+ years of experience in Clinical Quality for Director level and 10+ years in Clinical Quality for Sr. Director level leading teams in the biotech/pharmaceutical industry required
• Experience with FDA, TGA, PMDA, ICH and EMEA guidelines and regulations
• Excellent time management skills and the ability to work with a sense of urgency
• Strong oral and written communication including the ability to present information clearly and logically
• Ability to prioritize and manage multiple projects to meet critical deadlines
• Strong attention to detail and problem-solving skills
• Works effectively in a team environment