Senior QA Operations Lead – Sterile & Regulatory Compliance

ES45 (FCRS = ES045) Advanced Accelerator Applications Iberica S.L.U.; Zaragoza; Sur place; EUR 45 000 - 84 000; Plein temps

Résumé du poste

Novartis is seeking a Quality Assurance Operations Lead for La Almunia de Doña Godina, Spain. You will oversee sterile injectable product release, QA operations, and compliance with GMP and regulatory standards, ensuring inspection readiness and a strong quality culture on site.

Applicants should have 5+ years in pharma QA, a degree in pharmacy/chemistry/biology, and fluency in Spanish and English. The role supports cross-functional collaboration, ongoing improvements, and staff development in a

Qualifications

• Minimum 5+ years in the pharmaceutical industry with QA Operations experience.
• Strong knowledge of cGMP regulations and regulatory standards.
• Solid understanding of aseptic processes and aseptic manufacturing practices.
• Excellent organizational skills, attention to detail, and teamwork.
• Fluent in Spanish and English, both written and spoken.

Responsabilités

• Lead implementation and continuous improvement of QA compliance across site.
• Oversee QA Operations activities including product release and documentation management.
• Ensure quality oversight of manufacturing operations and qualification activities.
• Manage quality processes: OOS/OOT/OOE, deviations, CAPA, complaints and recalls.
• Escalate quality/cGMP issues and communicate with stakeholders and authorities when required.
• Support audits, inspections, and annual quality reviews.
• Monitor quality performance and drive improvements with site leadership.

Connaissances

QA Leadership

GMP Compliance

Regulatory Knowledge

Attention to Detail

Team Management

Formation

Science degree in Pharmacy, Chemistry, or Biology

Description du poste

Novartis is seeking a Quality Assurance Operations Lead for La Almunia de Doña Godina, Spain. You will oversee sterile injectable product release, QA operations, and compliance with GMP and regulatory standards, ensuring inspection readiness and a strong quality culture on site.

Applicants should have 5+ years in pharma QA, a degree in pharmacy/chemistry/biology, and fluency in Spanish and English. The role supports cross-functional collaboration, ongoing improvements, and staff development in a