摘要
Location: Barcelona, Spain #LI-Hybrid
This role is based in Barcelona, Spain. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
About the Role
Responsibilities:
- Lead global qualification and oversight of radiopharmacies in clinical trials, ensuring compliance with Novartis and regulatory standards
- Act as the single point of contact for Radiopharmacy QA processes, supporting qualification, requalification, and continuous oversight activities
- Collaborate with global and local teams to ensure seamless communication and execution of Radiopharmacy QA strategies
- Identify and manage risks related to Radiopharmacy qualification and oversight, ensuring mitigation plans are implemented and effective
- Support audit and inspection readiness, including knowledge transfer and documentation preparation for local QA teams
- Maintain and contribute to SOPs and written processes related to Radiopharmacy QA, ensuring alignment with global standards
- Drive continuous improvement initiatives using insights from audits, inspections, and quality performance reviews
- Investigate GMP/GCP issues at radiopharmacies, ensuring robust CAPA plans and timely escalation when needed
Essential for the role:
- Bachelor’s degree in Pharmacy, Biology, Chemistry or a closely related scientific discipline
- Minimum 5 years of experience in a pharmaceutical Quality Assurance role, ideally within clinical development or radiopharmaceuticals
- In-depth understanding of Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and pharmacovigilance regulations and international guidelines
- Proven track record in managing qualification and oversight of radiopharmacies, including supplier selection and compliance monitoring
- Strong interpersonal and communication skills, with the ability to collaborate effectively across global and cross-functional teams
- Demonstrated ability to identify, assess, and mitigate quality risks, including root cause analysis and implementation of corrective actions
- Experience in preparing for and supporting audits and health authority inspections, including documentation and stakeholder coordination
- Fluent in English, with excellent written and verbal communication skills for technical and regulatory contexts
Desirable for the role:
- Familiarity with USP <825> and European guidelines on current good radiopharmacy practices (cGRPP)
- Experience working within radioligand therapy (RLT) programmes or with radiopharmaceuticals in clinical development; GCP experience would be considered a plus.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
