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

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 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 …