See Yourself at Telix 

The Quality Lead will provide QA leadership, oversight and support of Telix’s product disposition of development products manufactured and tested at Contract Manufacturing organizations and Contract Development Manufacturing organizations (CMOs and CDMOs). This position will ensure that Sponsor Quality oversight for commercial drug products as well as labelled and packaged products are completed on time and in accordance with cGMP, international regulatory requirements, internal policies, procedures and specifications. The Quality Assurance Product Lead will also lead Quality associated commercialization activities for late-stage development projects/products. This includes coordinating and leading the related activities with External Manufacturing, Regulatory Affairs, Operations, and Supply Chain to ensure Telix’s products are dispositioned on time to meet supply and customer requirements.

Key Accountabilities: 

• Act as the Quality Lead in cross functional project meetings, and lead review of technical documents to discuss product issues
• Author, review, and approve documents within Telix Quality Management System (QMS).
• Provide oversight for deviations, investigations, CAPA and change controls with QA associates.
• Collaborate and partner with production / manufacturing / project / program management teams to monitor work according to requirements under Telix quality system.
• Assure vendor compliance with Telix quality and regulatory requirements by monitoring key quality deliverables and communicating clear expectations to key third parties. Lead escalation process for any issues requiring management decisions.
• Review and evaluate all standard operating procedures, batch records and quality control results to ensure compliance with Telix quality and regulatory requirements
• Participate in and perform batch release of manufactured batches.
• Assure appropriate quality risk management principles are employed to ensure a level of compliance commensurate with stage of product lifecycle.
• Personal development – maintain standard knowledge up to date with global GMP and regulatory requirements and make recommendations for professional development and training.

Education and Experience:

• Bachelor’s degree in science related discipline (e.g., Chemistry, Biology, Pharmacology, Microbiology, etc.) required
• 5+ years’ experience in GMP within the pharmaceutical/biotechnology industry required
• Strong technical Quality background in API and Parenteral GMP manufacturing
• Ability to communicate effectively in all levels of an organization, especially with senior leadership
• Strong experience in quality from pharmaceutical/biotechnology industry
• Experience writing and reviewing Standard Operating Procedures
• Experience in reviewing and releasing manufactured batches
• Experience in writing, reviewing, and approving investigations and change controls
• Knowledge of applicable regulations (e.g., US FDA, EMA, ICH, PIC/S, WHO, etc.)
• Experience with quality risk management, reporting of non-conformances, CAPA management and change management.
• Radiopharmaceutical industry experience preferred
• Ability to travel domestically and internationally (approximately 30-50%)

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