15 oct
|
ES06 (FCRS = ES006) Novartis Farmacéutica
|
Barcelona
15 oct
ES06 (FCRS = ES006) Novartis Farmacéutica
Barcelona
Salary Range: €85,100.00 - €158,100.00
La siguiente información ofrece un resumen de las habilidades, cualidades y cualificaciones necesarias para este puesto.
Job Description Summary #LI-Hybrid
Location Barcelona, Spain
Relocation Support: This role is based in Barcelona. Novartis is unable to offer relocation support: please only apply if accessible.
Novartis operates a Hybrid working policy with an expectation of 12 days per month onsite.
Quality, compliance, and operational excellence are critical to how Novartis delivers innovative medicines to patients worldwide.
Key Responsibilities
- Provide compliance oversight and control of regulated Global Clinical Operations activities across assigned Development Units and clinical trial portfolios.
- Lead, coach, mentor, and develop a high-performing team of GCP Compliance Managers, fostering engagement, growth, and accountability.
- Drive compliance oversight of programs and trials within assigned Development Units, ensuring alignment with Good Clinical Practice, regulatory requirements, and internal standards.
- Oversee Clinical Trial Team Good Clinical Practice Compliance support activities, strengthening operational excellence and quality delivery across the portfolio.
- Ensure effective management of quality issues, deviations, and quality events within assigned scope, including appropriate escalation and risk mitigation.
- Lead audit and inspection readiness activities, including preparation, execution, response management and corrective and preventive action development.
- Oversee assigned Good Clinical Practice Compliance delivery pillars, including audits, inspections, quality issues, and self-assessment activities across the General Clinical Operations portfolio.
- Identify, assess, analyse, and communicate quality and compliance trends, ensuring timely action and informed decision-making.
- Partner with Development Unit leadership, Clinical Trial Teams, Quality, and cross-functional stakeholders to strengthe
📌 GCP Compliance Director (Barcelona)
🏢 ES06 (FCRS = ES006) Novartis Farmacéutica
📍 Barcelona