[Hiring] Senior Manager, Commercial Product Quality @Telix Pharmaceuticals (AMER)

Role Description

The Senior Manager, Commercial Product Quality is responsible for providing strategic and operational quality leadership across Chemistry, Manufacturing, and Controls (CMC) activities to ensure compliance with global Good Manufacturing Practice (GMP) requirements. This role partners cross-functionally with Manufacturing, Quality Control, Operations, Regulatory Affairs, and external manufacturing partners (CMOs/CDMOs) to drive quality excellence, inspection readiness, and robust control strategies throughout the product lifecycle.

The position leads the development and execution of quality strategies that support commercial and commercializing programs, ensuring that manufacturing processes, analytical methods, and control systems are designed, qualified, and maintained in a state of compliance. The Senior Manager provides oversight of GMP activities including batch disposition, deviation management, change control, and validation, while proactively identifying and mitigating quality and compliance risks.

This role is also accountable for establishing and strengthening quality systems, driving continuous improvement initiatives, and ensuring alignment with regulatory expectations. As a key influencer, the Senior QA Manager builds strong relationships across internal teams and external partners, enabling effective governance and decision-making without direct authority.

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, Illuccix®, Gozellix®, and TLX090 (153Sm-DOTMP) 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.

Qualifications

• Bachelor’s degree in a relevant scientific discipline such as Pharmaceutical Sciences, Life Sciences (Chemistry, Biochemistry, Microbiology, etc.), Pharmacy, Engineering; advanced degree preferred.
• 8+ years experience in Quality within the pharmaceutical or biotechnology industry, Manufacturing, Tech Services, and/or Regulatory Affairs.
• Strong understanding in GMP, Quality Management Systems, Risk Management, Regulatory frameworks (FDA, EMA, ICH guidelines, etc.).
• 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.

Requirements

• 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 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.
• Monitor performance metrics and establish trending programs.
• Demonstrate in-depth knowledge of regulatory requirements in the life sciences industry.
• Practice meticulous documentation and record-keeping to track activities, decisions, and transactions.
• Develop strategies to enhance cross-functional collaboration.
• Mentor and guide QA professionals, fostering a collaborative environment to enhance team performance.
• Facilitate decision-making, including risk assessment and analysis aligned with health authority requirements.
• Identify areas for process enhancement, utilizing metrics and feedback to drive continuous improvements.

Benefits

• Competitive salaries.
• Annual performance-based bonuses.
• Equity-based incentive program.
• Generous vacation and paid wellness days.
• Support for learning and development.