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 Quality Lead will oversee all quality control processes, ensuring our products meet the highest standards of quality and regulatory compliance. This role requires advanced knowledge of quality control principles, Good Manufacturing Practices (GMP), and regulatory requirements. The Quality Lead will lead quality control projects, mentor junior staff, and collaborate with cross-functional teams to drive continuous improvement initiatives.
Key Accountabilities
* Management of operational QC laboratories
o Coordinate and participate in development and validation of analytical methods for QC at TMS
o Manage activities outsourced to external labs related to TMS QC testing
o Development of raw material and product specifications for TMS production
o Setting up and managing stability studies for TMS production
o Lead routing QC testing, some requiring handling of radioactive substances (short-lived isotopes)
o Responsible for QC material (consumables and chemicals)
* Management of operational team
o Lead QC team at TMS
o Manage 1 year plan for the department, implementing changes as needed
* Audit and compliance
o Support in external audit for suppliers or subcontractors
* Instrument calibration and maintenance
o Manage lab equipment (maintenance, calibration, qualification, requalification)
o Manage deviations, out-of-specification results, and the implementation of corrective and preventative actions related to QC activities
* Data integrity and documentation
o Manage the creation and updates of Quality Control procedures
o Participate in investigations of customer complaints
o Manage adherence to GMP policies and procedures for all internal QC activities at TMS
Education And Experience
* Bachelor's degree in life sciences, biotechnology, chemistry, biology, or related field
* 5+ years' experience in a quality control within life sciences, pharmaceutical, biotechnology, or related industry
* Comprehensive understanding of advanced quality control principles, practices, and methodologies.
* Strong knowledge and practical experience with Good Manufacturing Practices (GMP) and their application in a quality control environment.
* Proficiency with laboratory equipment, techniques, and procedures used in quality control testing.
* Advanced analytical skills for interpreting complex data and performing sophisticated testing.
* Extensive knowledge of regulatory requirements related to quality control in the life sciences industry (e.g., FDA, EMA).
* Experience in preparing for and supporting internal and external audits.
* Ability to write detailed and precise quality control reports and SOPs.
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
At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development. Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. VIEW OUR PRIVACY POLICY HERE #J-18808-Ljbffr