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

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with a mission to deliver on the promise of precision medicine through targeted radiation. The Senior QA Manager, Commercial Product Quality plays a pivotal role in ensuring the highest standards of product quality and compliance within commercial operations, overseeing quality management systems and driving continuous improvement initiatives.

Responsibilities:

• 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
• 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
• 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
• Monitoring performance metrics
• Establishing trending programs
• Performing statistical analysis
• Establishment of acceptance criteria
• 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
• 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
• Develop strategies to enhance cross-functional collaboration
• Mentor and guide QA professions, fostering a collaborative environment to enhance team performance
• Problem-solve cross-functional issues to ensure appropriate relationships with contracted suppliers
• Drive Risk Assessment strategies that mitigate potential issues, ensuring compliance with industry standards and best practices
• Facilitate decision-making, including risk assessment and analysis aligned with health authority requirements
• Take ownership of actions and decisions, earning credibility through consistent delivery
• Grow cross-functional relationships with diverse and efficient thinking, fostering creative approaches
• Navigate through periods of change in company prioritizations, encouraging resilience in others

Requirements:

• Bachelor's degree in a relevant scientific or engineering field required
• 8+ years of experience in quality within the pharmaceutical or biotechnology industry
• Knowledge of statistical techniques and methodologies for quality assurance
• Proven experience in developing and managing quality management systems in a regulated environment
• Strong understanding of global regulatory requirements, including FDA and EMA regulations
• Excellent leadership and communication skills with the ability to influence and collaborate across departments
• Demonstrated success in driving continuous improvement initiatives and achieving measurable results
• Experience in risk management, root cause analysis, and CAPA (Corrective and Preventive Action) processes
• Demonstrate familiarity and compliance with ICH and GMP standards from health authorities worldwide
• Educate business partners on fit-for-purpose GxP requirements
• Ensure manufacturing processes meet established quality standards through a formalized system
• Maintain cross-functional relationships with key business partners to guarantee compliance
• Collaborate with matrix teams on pipeline products, addressing Quality needs
• Work closely with contracted manufacturing, testing, or supply chain entities
• Monitoring performance metrics
• Establishing trending programs
• Performing statistical analysis
• Establishment of acceptance criteria
• Demonstrate in-depth knowledge of regulatory requirements in the life sciences industry
• Communicate and educate cross-functional business partners on regulatory expectations
• Provide an assessment of risk when requirements cannot be completely integrated
• Practice meticulous documentation and record-keeping
• Collaborate with cross-functional business partners and third-party suppliers
• Develop strategies to enhance cross-functional collaboration
• Mentor and guide QA professions
• Problem-solve cross-functional issues
• Drive Risk Assessment strategies
• Facilitate decision-making, including risk assessment and analysis
• Take ownership of actions and decisions
• Grow cross-functional relationships with diverse and efficient thinking
• Navigate through periods of change in company prioritizations
• Advanced degree preferred