Quality Assurance Compliance Lead

About the role

Novartis is looking for a Quality Assurance Compliance Lead for its La Almunia site in La Almunia de Doña Godina, Zaragoza, Spain. The role helps maintain a strong quality culture so that medicines are made according to Good Manufacturing Practice and regulatory requirements. It works across teams to strengthen inspection readiness, quality systems, supplier oversight and continuous improvement. Relocation support is not offered; only apply if you can access the site.

Key responsibilities

• Ensure site Quality Systems comply with GMP regulations and Novartis quality standards
• Lead inspection readiness and support regulatory inspections, corporate audits and corrective and preventive actions
• Plan and support Product Quality Reviews, self-inspections and the Site Quality Plan
• Oversee supplier quality activities, including Quality Assurance Agreements and supplier audits
• Coordinate Quality Management Reviews and monitor Key Quality Indicators
• Support qualification, validation, change control and quality documentation
• Provide oversight of data integrity, electronic compliance and process quality assurance
• Support quality escalations, product recalls, market withdrawals, returns and other commercial product quality actions

Required profile

• Bachelor's degree or higher in Pharmacy, Biochemistry, Chemistry, Biology, Engineering or a related life science discipline
• At least four years of pharmaceutical industry experience, with direct exposure to compliance and Quality Systems
• Fluent written and spoken Spanish and English
• Desirable: experience as a certified Qualified Person in a high-tech production environment

Required skills

• Good Manufacturing Practice, Good Clinical Practice and Pharmacovigilance
• Regulatory Quality Systems and risk assessment and risk management
• Data integrity, Quality Management Systems, supplier quality management and statistical process control

What we offer

• Expected annual base salary of EUR 45,100 to 83,700, depending on skills, competencies and experience
• Possible performance-based bonus
• Insurance plans, retirement plans and wellbeing resources
• Flexible and hybrid working where possible, and at least 14 weeks of paid parental leave