Senior Manager, Commercial Product Quality (TLX250-CDx and TLX101-CDx)

See Yourself at Telix

The Senior QA Manager, Commercial Product Quality plays a pivotal role in ensuring the highest standards of product quality and compliance within our commercial operations. This position requires a seasoned professional with extensive experience in quality assurance, data monitoring, and a proven track record of success in the pharmaceutical or biotechnology industry by leading/influencing high-performing teams. With a deep understanding of product lifecycles and QA methodologies, the successful candidate will be responsible for overseeing and enhancing quality management systems, driving continuous improvement initiatives, overseeing contract manufacturing organizations, and collaborating with cross-functional teams with a focus on two of our key product projects, TLX250-CDx and TLX101-CDx (18F-FET) moving through the commercialization space to commercial product lifecycles.

This role is ideal for a proactive leader passionate about quality, committed to delivering exceptional products, and eager to contribute to the continuous growth and success of their organization.

Key Accountabilities

• Good Manufacturing Practices (GMP)
  • Demonstrate familiarity and compliance with ICH and GMP standards from health authorities worldwide, and guidelines governing the production of Active Pharmaceutical Ingredient (API) Drug Substance, Pharmaceutical Drug Products, Radiopharmaceuticals and medical devices.
  • Educate business partners on fit-for-purpose GxP requirements, ensuring a comprehensive understanding across teams.
• Quality Management Systems in Manufacturing
  • Ensures manufacturing processes meet established quality standards through a formalized system
  • Maintain cross-functional relationships with key business partners to guarantee compliance across the scope of manufacturing operations.
• Quality Assurance and Control
  • Collaborate with matrix teams on pipeline products, addressing Quality needs at the earliest stages of commercialization.
  • Work closely with contracted manufacturing, testing, or supply chain entities to align their output with Telix commercial needs.
• Data Analysis
  • Monitoring performance metrics
  • Establishing trending programs
  • Performing statistical analysis
  • Establishment of acceptance criteria
• Regulatory Compliance
  • Demonstrate in-depth knowledge of regulatory requirements in the life sciences industry.
  • Communicate and educate cross-functional business partners on regulatory expectations and provide analytical insights.
  • Provide an assessment of risk when requirements cannot be completely integrated.
• Documentation and Record-Keeping
  • Practice meticulous documentation and record-keeping to track activities, decisions, and transactions.
  • Collaborate with cross-functional business partners and third-party suppliers to ensure all required documentation is captured within Telix, meeting fit-for-purpose criteria.
• Leadership
  • Develop strategic initiatives to drive quality and compliance.