Senior Manager Quality Assurance, Country Development

Senior Manager Quality Assurance, Country Development

Job ID REQ-10051936

May 28, 2025

Spain

Summary

About the Role

The RPAC QA is responsible for planning and managing qualification activities with assurance of quality and compliance related to the regulatory landscape. This includes overseeing Site (SRP) and Central Radiopharmacies (CRP), as well as global, regional, or country-level vendors providing Apheresis and Cryopreservation services for clinical trials.

The RPAC QA collaborates with global and local RDQ and GCO colleagues (TRD QA, Study Lead, Study-Start-up Teams, CRAs, etc.) to ensure clear communication of activities and adherence to Novartis requirements and health authority regulations.

Responsibilities also include supporting health authority inspections and audits, leading projects such as developing quality risk management strategies, and continuous process improvement.

Major Accountabilities

1. Service Provider Management: Oversee implementation, maintenance, and monitoring of RPAC service providers globally, ensuring processes comply with GCP, PV, GMP, and applicable regulations.
2. SP Qualification: Execute QA activities for qualification/requalification of service providers, ensuring proper processes are followed, and support global and local teams.
3. Risk Management: Identify and communicate risks related to SP qualification and oversight, coordinate risk-based audits, and collaborate on mitigation strategies.
4. Audits and Inspections: Support audit and inspection readiness and knowledge transfer.
5. SOPs and Processes: Maintain plans for SOPs related to SP qualification and oversight, and contribute to training deployment.
6. Training and Communication: Develop and execute plans for communicating and training stakeholders on SOPs, processes, timelines, and product information.
7. Continuous Improvement: Use lessons learned from audits, inspections, and KPIs to recommend and implement improvements.
8. Quality Issue Management: Oversee investigations of GCP/GMP issues, ensure CAPA implementation, and escalate non-compliance as needed.

Key Performance Indicators

• Timely qualification of service providers for study start-up
• Proactive risk identification and mitigation
• Minimized GCP/PV/GMP issues during audits
• No regulatory delays due to SP qualification processes

Ideal Background

• Degree in Life Sciences or related fields
• Over 7 years of experience in the pharmaceutical industry in QA, regulatory affairs, PV, or related areas
• At least 3 years in clinical development
• Experience in Blood Bank, Tissue Bank, or Nuclear Medicine is advantageous
• Experience in RLT and/or CGT, GMP, project leadership, and vendor management
• Stakeholder management experience is a plus

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