Full-Time

Quality Lead

Development Quality

Posted on 6/6/2024

Telix Pharmaceuticals

Telix Pharmaceuticals

201-500 employees

Develops radiopharmaceuticals for cancer and rare diseases

Biotechnology

Senior

Remote in USA

Requirements
  • Bachelor’s degree in science related discipline
  • 5+ years’ experience in GMP within the pharmaceutical/biotechnology industry
  • Strong technical Quality background in API and Parenteral GMP manufacturing
  • Experience writing and reviewing Standard Operating Procedures
  • Experience in reviewing and releasing manufactured batches
  • Experience in writing, reviewing, and approving investigations and change controls
  • Knowledge of applicable regulations (e.g., US FDA, EMA, ICH, PIC/S, WHO, etc.)
  • Experience with quality risk management, reporting of non-conformances, CAPA management and change management
  • Radiopharmaceutical industry experience preferred
  • Ability to travel domestically and internationally (approximately 30-50%)
Responsibilities
  • Act as the Quality Lead in cross functional project meetings
  • Author, review, and approve documents within Telix Quality Management System (QMS)
  • Provide oversight for deviations, investigations, CAPA and change controls with QA associates
  • Collaborate and partner with production / manufacturing / project / program management teams
  • Assure vendor compliance with Telix quality and regulatory requirements
  • Review and evaluate all standard operating procedures, batch records and quality control results
  • Participate in and perform batch release of manufactured batches
  • Assure appropriate quality risk management principles are employed
  • Personal development – maintain standard knowledge up to date with global GMP and regulatory requirements

Telix Pharmaceuticals Limited is committed to improving patient outcomes by developing targeted radiopharmaceuticals for cancer and rare diseases. This company is a desirable place to work because of its focus on pioneering personalized therapies and disease imaging solutions. Employees at Telix are part of a supportive environment where innovation is encouraged, aimed at securing global regulatory approvals and maintaining a robust supply chain.

Company Stage

Grant

Total Funding

$63.5M

Headquarters

North Melbourne, Australia

Founded

2015

Growth & Insights
Headcount

6 month growth

17%

1 year growth

47%

2 year growth

139%
INACTIVE