Manager, Clinical Quality
Location: USA – Remote
Updated: Wednesday, 29 October 2025
About Telix Pharmaceuticals
Telix Pharmaceuticals is a fast-growing, global radiopharmaceutical company headquartered in Australia, with offices in Belgium, Japan, Switzerland, and the United States.
Our mission is to deliver on the promise of precision medicine through targeted radiation, improving the quality of life for people living with cancer and rare diseases.
You will support the international rollout of our approved prostate cancer imaging agent and contribute to advancing our portfolio of late clinical-stage products addressing major unmet needs in oncology and rare diseases.
Position Summary
The Manager, Clinical Quality plays a key role in establishing, implementing, and maintaining quality assurance processes and procedures to ensure Telix’s clinical trials are conducted in full compliance with GCP (Good Clinical Practice), GVP (Good Pharmacovigilance Practice), and GCLP (Good Clinical Laboratory Practice) standards.
This role is responsible for planning, conducting, and reporting audits and assessments of vendors, clinical investigator sites, laboratories, databases, systems, and internal processes — ensuring accuracy, integrity, and compliance.
This position will provide quality oversight and compliance support across Telix’s early- and late-stage assets.
Key Responsibilities
Audit & Compliance Oversight
Plan, schedule, and conduct GCP, GVP, and GCLP audits of investigator sites, CROs, laboratories, and vendors.
Develop and maintain audit plans, agendas, and reports, track audit responses, and manage CAPA implementation.
Oversee inspection readiness for regulatory GCP/GCLP/GVP inspections and support inspection response coordination.
Quality Assurance & Risk Management
Provide quality oversight to study and program teams by representing Clinical Quality in meetings and document reviews.
Review and close temperature excursions, product complaints, and clinical trial–related investigations.
Evaluate critical processes and procedures to identify risks and implement preventive actions.
Process Improvement & Documentation
Contribute to the development, review, and revision of SOPs, Work Instructions, and Forms in collaboration with Clinical Operations.
Participate in initiatives to improve risk management, data integrity, trial conduct, and investigational product management.
Education & Experience Requirements
Bachelor’s degree in Life Sciences or a related discipline (Master’s preferred).
ASQ Certification in Quality Auditing, Quality Management, or Six Sigma (Green/Black Belt) preferred.
7+ years of experience in Clinical Quality (Manager level) or 9+ years (Senior Manager level) in biotech/pharma leading teams.
In-depth knowledge of FDA, TGA, PMDA, ICH, and EMA guidelines and regulations.
Strong audit planning, documentation, and CAPA management experience.
Excellent oral and written communication skills with logical presentation abilities.
Proven ability to prioritize multiple projects and meet critical deadlines.
High attention to detail, analytical thinking, and problem-solving skills.
Effective team collaboration and leadership experience.
Key Capabilities
Ethical Behavior: Uphold integrity and high ethical standards in all actions.
Collaboration: Foster teamwork and knowledge sharing to achieve goals.
Commitment to Excellence: Deliver consistent, high-quality performance.
Strong Communication: Communicate clearly with internal and external stakeholders.
Accountability: Take ownership of outcomes and ensure compliance with standards.
Why Join Telix
At Telix, we believe everyone counts. You’ll be part of an engaged, interdisciplinary global team working together to advance the future of precision medicine.
We offer:
Competitive salary and annual performance-based bonuses
Equity-based incentive program
Generous vacation and wellness days
Support for continuous learning and professional development
Flexible hybrid and remote work options
Equal Opportunity Statement
Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristic.
🔗 Apply Now
For more information on Telix’s global roles, visit our LinkedIn page.
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