Quality Assurance Specialist

Telix Pharmaceuticals Limited; Herstal; Hybride; EUR 50 000 - 70 000; Plein temps

Avantages offerts par ce poste

Competitive salaries

Annual performance-based bonuses

Equity-based incentive program

Generous vacation

Paid wellness days

Support for learning and development

Résumé du poste

Telix Pharmaceuticals Limited in Herstal, Belgium, seeks a Quality Assurance Associate to support GMP-compliant quality management during commercial-scale-up across Europe, expanding MAH, secondary packaging and distribution operations.

The role requires a Bachelor's in science and 2+ years in a regulated quality role; English and French fluency are essential. The position reports to the local Senior Quality Assurance Manager and offers hybrid work options.

Qualifications

• Bachelor’s degree required; orientation in pharmacy, biochemistry or science preferred.
• 2+ years of quality experience in a regulated industry.
• Knowledge of EU and USA regulations.
• English and French fluency.

Responsabilités

• Adhere to GMP policies and Telix QMS requirements.
• Prepare, review and approve documents within QMS/eQMS and Master Control.
• Maintain quality system registers and provide training on Telix QMS.
• Participate in deviations, investigations, CAPA, change control and complaint reports.
• Support internal quality audits and report findings under Senior QA Manager guidance.
• Manage supplier quality audits, supplier quality agreements and CMOs compliance.
• Collaborate with production to ensure quality across operations and batch records.
• Support batch release activities for commercial and clinical products as needed.
• Identify system/process gaps and drive corrective/preventive actions.
• Engage in continuous professional development and learning.

Connaissances

GMP understanding

Quality management

Document review

Cross-functional collaboration

Communication skills

Adaptability

Continuous learning

Team collaboration

Formation

Bachelor's degree in pharmacy/biochemistry/science

Outils

eQMS

MasterControl

Description du poste

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 Assurance Associate will contribute to the achievement of the Group’s strategic quality goals by supporting the quality management of the commercial scale-up following GMP requirements in Europe. Coordinate and assist in the active management and implementation of the Telix commercial program/s as directed, including aspects of quality requirements. Actively participating in and supporting the quality needs of the commercial programs across the organisation’s country jurisdictions especially the expansion of the MAH, secondary packaging & distribution operations. Provide support to other TLX programs and other team members as required. The role is located in Telix Innovations, Herstal (Belgium) with the role reporting to the local Senior Quality Assurance manager.

Key Accountabilities

• Understand and adhere to GMP Policies.
• Prepare, review and approve documents within Telix Quality Management System (QMS) and eQMS, Master Control.
• Maintain quality requirements, quality system registers and training on Telix QMS.
• Participate in writing, implementing and approving Deviations, Investigations, CAPA Change Control and complaint reports.
• Participate in the management and completion of internal quality audits on all Telix systems within the QMS, prepare reports and recommend solutions and close out activities under the guidance of the Senior Quality Assurance Manager.
• Participate in the management of supplier quality audits, vendor assurance activities and supplier quality agreements.
• Participate in the management of CMOs (vendors involved in manufacturing, production and quality control) and other external suppliers (vendors involved in distribution) in compliance with EU GMDP and other global requirements.
• Collaborate with production/manufacturing teams to monitor all work according to requirements under Telix quality system. Review and evaluate all standard operating procedures, batch records and quality control results to ensure compliance with Telix quality and regulatory requirements.
• Participate in batch release activities for Telix in the QMS for commercial and clinical products (as required).
• Provide support to cross-functional team.
• Identify required system and process gaps within the Telix QMS and facilitate corrective and preventative actions as required.
• Personal development – maintain standard knowledge and make recommendations for professional development and training.

Education And Experience

• Bachelor’s degree required. Orientation in pharmacy, biochemistry or science field is highly preferred.
• 2+ years of experience in quality position from a regulated industry.
• Knowledge of applicable regulations within EU and the USA.
• Technical understanding of manufacturing, quality and regulatory requirements.
• Previous experience writing and reviewing with understanding SOPs and specifications.
• Languages: English and French fluency.

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
• 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.