Manager, Clinical Quality

Role Summary

The Manager, Clinical Quality will be part of a Telix team responsible for establishing, implementing and maintaining appropriate quality assurance processes and documented procedures to ensure that clinical trials are conducted and data are generated, recorded and reported in compliance with the protocol, GCP and the applicable regulatory requirement(s). This position will be dedicated to providing 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 Good Clinical Practices (GCPs), Good Pharmacovigilance Practices (GVP), and Good Clinical Laboratory Practices (GCLPs).
• Ensure accurate audit documentation from audits of Clinical Investigator Sites, CROs, supporting laboratories, monitoring organizations and other vendors by writing audit plans, audit agendas and audit reports as well as tracking audit responses and resulting CAPAs.
• Drive inspection preparation activities for regulatory authority GCP/GCLP/GVP inspections and guide coordination of 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.
• Ensure accurate and timely review, investigation and closure of temperature excursions, product complaints and clinical trial related investigations.
• 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 risk management, data management, trial management, and investigational product management.
• Collaborate with the Clinical Operations team to write, revise, and approve appropriate SOPs, Work Instructions and Forms.

Education and Experience

• Bachelor's degree in Life Sciences or related discipline, or equivalent experience in lieu of degree; Master’s 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 in Clinical Quality for Sr. Manager level leading teams in the biotech/pharmaceutical industry
• 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
• Travel: 10% - 20% a year

Key Capabilities

• Ethical Behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders.
• Collaboration: Work effectively as a part of a team, actively sharing knowledge and expertise to achieve common goals
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language.