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.