Experteer Overview
In this role you will lead the QA Operations on site to ensure sterile injectable products are released to the highest quality, in full regulatory compliance and patient safety. You collaborate with manufacturing, QA, and production leadership to maintain inspection readiness and drive continuous quality improvements. You shape the QA culture, manage people and processes, and provide strategic QA oversight across site operations. This position offers the opportunity to impact product quality and compliance at scale within a general pharma environment.

Compensaciones / Beneficios
• Lead implementation and improvement of quality standards compliance (GMP, EMA, AEMPS) and site procedures, fostering a strong quality culture.
• Oversee QA Operations tasks: product release, documentation, SOPs, training, resource planning, and shift organization for QPs and QA Officers.
• Ensure quality oversight of manufacturing activities including validation and qualification activities and new projects requiring QA support.
• Manage quality processes: deviations, CAPA, investigations, OOS/OOT/OOE, changes, recalls, complaints, and related corrective actions per cGMP and SOPs.
• Escalate and communicate quality issues to stakeholders and authorities when required.




• Support audits, inspections, and quality reviews; participate in self-inspections and annual training and Product Quality Review.
• Monitor quality performance through indicators; ensure timely project completion and business continuity in collaboration with site leaders.
• Provide QA support to commercial operations while ensuring environmental, safety, and communication requirements are met.

Responsabilidades
• 5+ years in the pharmaceutical industry with strong QA Operations knowledge
• Solid understanding of cGMP, regulatory requirements, and pharmaceutical quality standards
• Experience with aseptic processes and aseptic manufacturing
• Excellent organization, attention to detail, teamwork, and urgency in task execution
• Strong communication and collaboration skills for cross-functional production support
• Fluent in Spanish and English (written and spoken)
• Desirable: experience as a certified Qualified Person

Requisitos principales
• flexible and hybrid working options
• minimum of 14 weeks paid parental leave
• insurance plans
• retirement plans
• wellbeing resources
• global recognition programs

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