Quality Specialist, Development Quality
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
See Yourself at Telix
The Quality Assurance Specialist will effectively review and approve key documents generated by CDMO/CMO including facilitation and creation of nonconformances (deviations, issues, CAPA) within appropriate timelines. The QA Specialist will coordinate and assist in the active management of vendors and providing quality oversight to the Telix program/s as directed, including aspects of quality requirements. They will also actively participate in and support the quality needs of the programs across the organization’s country jurisdictions and provide support to other TLX programs and other team members as required.
Key Accountabilities
- Good Manufacturing Practices
- Collaborate with internal production and manufacturing team, and external CDMOs to monitor work according to GMP requirements
- Quality Management Systems in Manufacturing
- Prepare, review, and approve documents withing Telix PQS
- Support manufacturing and project team in the use of the PQS
- Quality Assurance and Control
- Participate in and perform batch release activities
- Review all SOPs, batch record and QC results to ensure compliance with quality and regulatory requirements
- Regulatory Compliance
- Knowledge of PIC/S GMP requirements, ICH guidelines, 21 CFR 210, 211, and 212
- Documentation and Record-Keeping
- Participating in writing and approving deviations, investigations, CAPAs and change controls
Education and Experience
- BA/BSc or higher education in science related discipline (e.g., Chemistry, Biology, Pharmacology, Microbiology, etc.) required
- Experience in quality within the pharmaceutical/biotechnology industry (3+ years)
- Experience writing and reviewing Standard Operating Procedures
- Experience in reviewing batch records manufactured by CMOs/CDMOs
- Experience in writing, reviewing, and approving investigations and change controls
- Experience with quality risk management
- Experience working in matrixed teams with external vendors
- Understanding of 21 CFR Part 210/211, ICH Guidelines, and PIC/S
- Radiopharmaceutical industry experience highly desirable
- Quality auditing experience preferred
- Ability to travel (approximately up to 10%)
At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
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, and other legally protected characteristics.
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