Manager, Clinical Quality

Role Summary

The Manager, Clinical Quality will establish, implement, and maintain quality assurance processes and documented procedures to ensure clinical trials are conducted and data are generated, recorded, and reported in compliance with the protocol, GCP, and applicable regulatory requirements. This role provides quality oversight and compliance support to Telix’s early and late-stage assets.

Responsibilities

• Plan, arrange, schedule and conduct audits and assessments to ensure compliance with GCP, GVP, and GCLPs.
• Ensure accurate audit documentation from audits of Clinical Investigator Sites, CROs, supporting laboratories, monitoring organizations, and other vendors by writing audit plans, agendas, and reports, and tracking audit responses and CAPAs.
• Drive inspection preparation activities for regulatory authority GCP/GCLP/GVP inspections and coordinate inspection responses.
• Provide Quality oversight and compliance support for Telix study, program, development, and matrix teams by attending meetings, representing Clinical Quality, and reviewing essential documents.
• Review and ensure timely investigation and closure of temperature excursions, product complaints, and clinical trial-related investigations.
• Identify gaps in standards, procedures, and technologies that pose risk to clinical trial quality and review critical processes accordingly.
• Participate in initiatives related to quality processes such as risk management, data management, trial management, and investigational product management.
• Collaborate with the Clinical Operations team to write, revise, and approve SOPs, Work Instructions, and Forms.

Qualifications

• Bachelor's degree in Life Sciences or related field, or equivalent experience; Master‚Äôs degree preferred
• ASQ Certification in Quality Auditing, Quality Management, Six Sigma Green Belt or Six Sigma Black Belt preferred
• 7+ years of experience in Clinical Quality for Manager level or 9+ years for Sr. Manager level leading teams in biotech/pharmaceutical industry
• Experience with FDA, TGA, PMDA, ICH and EMEA guidelines and regulations
• Excellent time management skills and ability to work with a sense of urgency
• Strong oral and written communication skills with ability to present information clearly
• 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

Skills

• Ethical behavior and integrity in professional interactions
• Collaboration and teamwork
• Commitment to excellence
• Clear and effective communication across all levels

Education

• Bachelor's degree in Life Sciences or related discipline; Master‚Äôs degree preferred

Additional Requirements

• None specified beyond the above role requirements