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
  • Connection
    • Develop strategies to enhance cross-functional collaboration
    • Mentor and quide QA professions, fostering a collaborative environment to enhance team performance
  • Creativity
    • 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
  • Courage
    • Facilitate decision-making, including risk assessment and analysis aligned with health authority requirements
  • Commitment
    • Take ownership of actions and decisions, earning credibility through consistent delivery
  • Curiosity
    • Grow cross-functional relationships with diverse and efficient thinking, fostering creative approaches
  • Change
    • Navigate through periods of change in company prioritizations, encouraging resilience in others

Education and Experience:

• Bachelor’s degree in a relevant scientific or engineering field required; advanced degree preferred
• 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

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills