Development Quality Assurance Manager [Radiopharmacy QA]

Development Quality Assurance Manager [Radiopharmacy QA]

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Summary

Provide quality assurance and compliance oversight to development and research functions. Drive quality management system and initiative oversight within the global, regional, and national organization, ensuring compliance with applicable regulatory requirements (e.g., GCP, GLP, GMP, PV, IP) and Novartis quality procedures and standards. Model quality behaviors while promoting a quality culture (e.g., first-time correctness) to positively impact non-quality stakeholders (e.g., NIBR, GDD). Develop, drive, and/or support quality plan initiatives to achieve organizational strategy, mission, and vision.

About The Role

The RP QA is responsible for assuring qualification activities are planned and managed with adequate quality and compliance assurance as it pertains to maintaining the regulatory landscape. Radiopharmacies may include Site Radiopharmacies (SRP) and Central Radiopharmacies (CRP). The RP QA will operate in direct collaboration with global and local Research & Development Quality (RDQ) and Global Clinical Operations (GCO) colleagues to ensure the scope of activities is clearly communicated and understood by receiving functions and actions taken follow Novartis requirements and relevant Health Authority (HA) regulations and guidance.

Major Accountabilities

• Radiopharmacy Management – Oversee implementation, maintenance, and monitoring of Radiopharmacies on a global level and written procedures to ensure GCP, Pharmacovigilance (PV), and GMP related processes and tasks are compliant with Novartis global requirements and applicable regulations and guidelines.
• ESP/Supplier Management: Responsible for the execution of QA activities required for the qualification/requalification of RPs.
• Risk Identification and Management – Identify any risks relevant to the RP Qualification and Oversight into Novartis and assure that those risks and any mitigation strategies are communicated to internal and external stakeholders.
• Audits and Inspections – Support audit and inspection readiness and knowledge transfer to local CDQ associates as needed to assure a successful audit and/or inspection.
• SOPs and Written Processes – Identify/maintain plans for RP Qualification and Oversight SOPs and Guidelines.
• Training and communication – Accountable for providing input to and/or developing and executing plans to communicate information and facilitate training for CDQ teams and other stakeholders.
• Continuous Improvement: Utilize lessons learned from audits, inspections, KQI reviews, and day-to-day oversight of quality performance to recommend and initiate continuous improvement efforts.
• Quality Issue Management: Oversee and drive relevant investigation activities of GCP and/or GMP issues at RPs as appropriate and ensure implementation of robust CAPA plans where applicable.

Key Performance Indicators

• Radiopharmacies are qualified in time for Study Start-up
• Monitoring/Trending KQIs for Radiopharmacies
• GCP/PV/GMP risks proactively identified and effectively mitigated.
• The number and severity of GCP/PV/GMP issues identified during internal and external audits is minimized
• No regulatory delays are encountered due to inefficient global RP qualification and oversight process

Ideal Background

• Degree in Life Sciences or related fields
• Typically, more than 7 years’ experience in the pharmaceutical industry in a relevant field such as quality assurance, regulatory affairs, pharmacovigilance, or a directly related area
• A minimum of 3 years’ experience in clinical development
• Experience in the radioligand environment (Blood Bank, Tissue Bank, or Nuclear Medicine experience would be advantageous)
• GMP experience
• Experience of leading projects and Vendor/service provider management
• External Service Providers (ESP) management
• Internal & external stakeholder management is an advantage.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives, and our vision is to become the most valued and trusted medicines company in the world.

Commitment To Diversity And Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams\’ representative of the patients and communities we serve.