Senior Manager, Quality – QP & Radiopharmacist

at  Telix Pharmaceuticals EMEA

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.
We are now recruiting a high calibre Senior Qualified Person (QP) to join our Quality team in Belgium. In this role you will contribute to the achievement of the Group’s strategic quality goals by leading the quality management following GMP requirements in Europe. As Senior QP, it is expected that the candidate has the Quality Assurance responsibility related to complex processes with an appropriate level of autonomy and has the responsibility for the QP position and release processes. You will coordinate and collaborate in the active management and implementation of the Telix products as directed, including aspects of quality requirements. Actively participating in and supporting the quality needs of the programs across the organisation’s regional country jurisdictions. Provide support to other TLX programs and other team members as required, to interact with key staff in the Australia or in the US as required.

KEY RESPONSIBILITIES:

• Understand and adhere to GMP Policies.
• Prepare, review and approve documents within Telix Quality Management System (QMS) and eQMS, Master Control:
• Provide support to cross-functional team
• Implement appropriate project management principles to ensure a level of compliance commensurate with stage of product lifecycle
• Implement appropriate quality risk management principles to ensure a level of compliance commensurate with stage of product lifecycle
• Investigate and resolve products and process problems related to quality issues
• Ensure CAPA’s and quality issues are properly documented, and corrective actions taken
• As required participate in the investigations of customer complaints, working with manufacturers and operations to resolution
• Ensure the release and handling of product for use in clinical trials, magistral use, and commercial activities is compliant with documented procedures, product specifications and regulatory dossiers
• Participate in communication with the regulatory agencies as need
• Personal development – maintain standard knowledge and make recommendations for professional development and training as a QP

To succeed in this role, you will have the following Education and Experience:

• Appropriate regulatory authorizations to work as QP in the radiopharmaceuticals field
• A Master degree in pharmacy and an additional Master degree in industrial pharmacy
• At least 10 years of Quality experience at pharmaceutical/biotechnology level
• At least 5 years of experience as QP (site or support, please specify in our application)
• Audit experience
• Experience in radiopharmaceuticals is a highly desired
• Experience in Project management is highly desired
• Previous experience writing and reviewing with understanding SOPs and specifications
• Experience in set-up a new manufacturing site is a plus,Strong written and oral communication skills required
• Languages: English and French fluency

Personal qualities:

• Commitment to the vision and mission of Telix
• Ability to work under pressure
• Ability and willingness to work collaboratively with global team members across multiple time zones
• Excellent interpersonal, communications and team participation skills
• Possess problem-solving skills
• A conscientious and rigorous attitude
• Positive growth mindset

AGENCY SUPPORT IS NOT REQUIRED FOR THIS ROLE AND NO SUBMISSIONS WILL BE CONSIDERED.

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.