<p>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. </p> <p>See Yourself at Telix</p> <p>The role is an EU-based Quality Manager position to support and maintain Medical Device Quality Management System (QMS) in operation, and to expand the existing QMS in order to incorporate 27001 and 42001 standards</p> <p>The Quality Manager ensures that the QMS is able to support the design, development, and commercialization of future products especially SaMD (software as a medica device) by ensuring regulatory and quality requirements are met to achieve appropriate global approvals in line with regulations and standards such as but not limited to EU MDR, ISO 13485, 21CFR820, ISO14971, IEC 62304; the QMS is currently ISO 13485 compliant.  The Quality Manager is responsible for maintaining the ISO 13485 core QMS functions (audit, CAPA, document control), and for ensuring that internal design teams follow the approved quality processes in place.</p> <p>The Quality Manager reports to the Senior Director Operations, Medical Technologies, and holds accountability for the quality responsibilities of Lightpoint's businesses and partnerships. In addition, the role will need to be able to support the execution of regulatory strategy that is established and agreed within the company using internal and external expertise as required.</p> <p>The Quality Manager will act as Management Representative for the QMS certification and will be responsible for the monitoring and improvement of the QMS and relevant procedures, ensuring compliance to these procedures to ensure R&D and commercialization can be completed through the approval of relevant Notified bodies.</p> <p>Key Accountabilities:</p> <ul> <li>Manage and support the monitoring and continuous improvement of the QMS in alignment with corporate and regulatory requirements </li><li>Audit, qualification and review of key service providers, manufacturing partners and supply chain. Serve as Management Representative in any audit by a regulatory authority / Notified Body and lead all audit communications with audit personnel from a regulatory agency. Support production of documents for technical file submissions. </li><li>Manage Quality operations for Lightpoint, ensuring effective execution of quality processes and compliance with established procedures. Collaborate with and provide functional leadership and support to team members in quality function. </li><li>Collaborate closely with the cross functionally within Lightpoint and establish relationships with Telix as appropriate to executing responsibilities. Ensure an efficient and effective quality management process. </li><li>Ensure release and handling of products (soft- and/or hardware) for use in clinical trials and commercially is compliant with documented procedures and product is within specification. </li><li>Maintain quality processes ensuring the validated state for commercial products is achieved and maintained. </li><li>Ensure application of Design Control as per standards (for example ISO 13485/IEC 62304) and regulations (for example 21CFR820) for product. </li><li>Ensure the identification and management of risks are robust and appropriate. </li><li>Operate within corporate Quality governance frameworks and escalate risks, deviations, and compliance concerns in accordance with established policies. </li><li>Works in accordance with Lightpoint and Telix values </li></ul> <p>Education and Experience:</p> <ul> <li>Bachelor's degree in Engineering, Life Sciences, Quality, Manufacturing, Regulatory, or other relevant field </li><li>5+ years of demonstrated experience with medical device QMS, EN ISO 13485, 21CFR820 and relevant standards for software as a medical device (IEC 62304), including the implementation of product risk management as outlined in ISO 14 971. </li><li>Experience with cross-functional management is preferred. </li><li>In-depth knowledge of core global medical device requirements, standards and regulations. </li><li>Experience in Software as a Medical Device; Design and Development and Maintenance </li><li>Fluent in English. </li></ul> <p>Personal qualities:</p> <ul> <li>Excellent interpersonal, communication and team participation skills. </li><li>Positive mindset (can do attitude). </li><li>Possess problem-solving skills. </li><li>Documentation skills. </li><li>A conscientious and rigorous attitude. </li><li>Commitment to the vision and mission of Telix and Lightpoint. </li><li>Ability to prioritize competitive priorities/ objectives. </li><li>Ability and willingness to work collaboratively with global team members across multiple time zones. </li></ul> <p>Key Capabilities:</p> <ul> <li>Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected </li><li>Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges </li><li>Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do </li><li>Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results </li><li>Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders </li><li>Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges </li><li>Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language </li><li>Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals </li><li>Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges </li><li>Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills </li></ul> <p> </p> <p>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. </p> <p>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. </p> <p>VIEW OUR RECRUITMENT PRIVACY POLICY HERE</p>