Overview

As QA Compliance Lead, you will strengthen the quality culture at the La Almunia site and ensure GMP and regulatory standards are met. You’ll collaborate with cross-functional teams to support inspections, supplier oversight, and continuous improvement, shaping how medicines are made. You will drive quality decisions, maintain inspection readiness, and oversee data integrity and quality documentation. This role offers meaningful impact by safeguarding patients and reinforcing confidence in our processes. You will work in a dynamic, global pharma environment with a focus on patient safety and regulatory excellence.

Compensaciones / Ventajas

- flexible and hybrid working options
- minimum 14 weeks paid parental leave
- insurance plans
- retirement plans
- wellbeing resources
- global recognition programs

Responsabilidades

- Ensure site Quality Systems comply with GMP and Novartis quality standards
- Lead inspection readiness and support regulatory inspections, corporate audits and CAPAs
- Plan and support Product Quality Reviews, self-inspections and Site Quality Plan execution
- Oversee supplier quality activities including QA agreements and supplier audits




- Coordinate Quality Management Reviews and monitor Key Quality Indicators for continuous improvement
- Support qualification, validation, change control and quality documentation across the site
- Provide oversight of data integrity, electronic compliance and process quality assurance requirements
- Support quality escalations, product recalls, market withdrawals, returns and other commercial product quality actions

Requisitos principales

- Bachelor’s degree or higher in Pharmacy, Biochemistry, Chemistry, Biology, Engineering or related life science
- At least four years of pharmaceutical industry experience with exposure to compliance and Quality Systems
- Strong knowledge of GMP, GCP and Pharmacovigilance requirements
- Solid understanding of regulatory Quality Systems in pharmaceuticals
- Strong knowledge of risk assessment and risk management principles and tools
- Fluent written and spoken Spanish and English with strong communication and collaboration skills

- Collaboration
- Communication
- Leadership
- Good Manufacturing Practice (GMP)
- Good Clinical Practice (GCP)
- Pharmacovigilance requirements

📌 Quality Assurance Compliance Lead (Zaragoza)
🏢 Novartis
📍 Zaragoza