Quality Manager Medical Technology

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.

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 incoming AI development platform(s), clinical decision support systems (CDSS) as Software as a Medical Device (SaMD) applications, as well as future incoming medical device(s). The Quality Manager ensures that the QMS is able to support the design, development, and commercialization of future products 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 managing the post market submission (PMS) and vigilance activities of the medical technologies business. The Quality Manager reports to the General Manager, 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. 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 Competent Authorities.

Key Accountabilities

• Develop and lead the monitoring and continuous improvement of the QMS compliant with relevant global jurisdictional medical device requirements.
• 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 preparation of documents for technical file submission.
• Lead quality at Lightpoint. Collaborate with and provide functional leadership and support to team members in quality function.
• 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.
• 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.
• Maintain quality processes ensuring the validated state for commercial products is achieved and maintained. Apply Design Control as per standards (for example ISO 13485/IEC 62304) and regulations (for example 21CFR820) for product.
• Establish, train and maintain a competent and capable workforce that can execute requirements, ensure regulatory requirements are met.
• Ensure the identification and management of risks are robust and appropriate.
• Works in accordance with Lightpoint and Telix values
  

About You

Education and Experience:

• Minimum 5 years’ 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.
• Minimum of 5 years’ experience in supervising and managing teams.
• In-depth knowledge of core global medical device requirements, standards and regulations.
• Experience in medical device (soft- and hardware) Design and Development and Product Realization.
• Fluent in English.