16 oct
|
Novartis
|
Barcelona
16 oct
Novartis
Barcelona
Experteer Overview In this role you will lead regional PV quality assurance oversight to ensure compliance with global, regional, and country vigilance regulations. You will collaborate with PS and PV teams to monitor performance, drive quality improvements, and maintain readiness for inspections. The position focuses on shaping risk-based quality programs, CAPA governance, and QMS enhancements across country organizations. This is a chance to impact patient safety and regulatory compliance at scale within a integral pharma leader.Compensaciones / Beneficios
- Lead regional quality oversight for Vigilance Quality Systems and risk management across country teams.
- Coordinate the Integral Vigilance Quality Plan execution and report status to Global PV QA.
- Monitor KPIs related to regional vigilance performance and ensure inspection readiness.
- Lead and govern CAPA plans from PV inspections and ensure sustainable closure in QMS.
- Provide expertise for PV issue investigations, CAPA remediation, and quality issue escalation.
- Support QRA, PSMF maintenance, and regional self-assessment programs.
- Drive quality improvements and share best practices across regions.
- Assist in due diligence and integration/divestment activities related to PV systems.Responsabilidades
- Degree in Life Sciences or related scientific discipline
- Excellent written and verbal English; second language a plus
- PV/QA/regulated industry experience with audits or inspections a plus
- Experience in PV within country organizations plus global quality support a plus
- Ability to travel up to 20%
- Strong problem solving, decision making, and prioritization skills
- Quality mindset and leadership with facilitation skills
- Extensive knowledge of PV regulations, GCP, GMP, and QMS
- Ability to lead teams in diverse cultural environments
- Capacity to deputize for Global Head PV QA Regions and Countries as neededRequisitos principales
- base salary
- performance-based bonus
- insurance plans
- retirement plans
- wellbeing resources
- hybrid working options
📌 Regional Head, Pharmacovigilance Quality (Barcelona)
🏢 Novartis
📍 Barcelona