QA Compliance Lead — Elevate Site Quality & Readiness

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

Avantages offerts par ce poste

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

14 weeks parental leave

Résumé du poste

Advanced Accelerator Applications Iberica S.L.U. in La Almunia de Doña Godina, Spain, seeks a QA Compliance Lead to ensure GMP-aligned quality systems, support inspections, supplier oversight, and continuous improvement across the site.

You will collaborate across teams to maintain inspection readiness, execute the Site Quality Plan, and manage data integrity and regulatory compliance. The ideal candidate has a life-sciences degree, 4+ years in pharma compliance, and fluency in Spanish and

Qualifications

• Bachelor’s degree or higher in Pharmacy, Biochemistry, Chemistry, Biology, Engineering or life sciences.
• At least four years of pharmaceutical industry experience with compliance and Quality Systems.
• Strong knowledge of GMP, GCP and Pharmacovigilance requirements.
• Fluent written and spoken Spanish and English, with strong communication and collaboration skills.

Responsabilités

• Ensure site Quality Systems comply with GMP regulations and Novartis quality standards.
• Lead inspection readiness and support regulatory inspections, audits and CAPAs.
• Plan and support Product Quality Reviews, self-inspections and Site Quality Plan.
• Oversee supplier quality activities, including QAAs and supplier audits.
• Coordinate Quality Management Reviews and monitor KPIs to drive improvement.
• 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 and other quality actions.

Connaissances

Quality Systems

Regulatory Compliance

Risk Management

Bilingual Spanish/English

Communication skills

Formation

Life sciences degree

Description du poste

Advanced Accelerator Applications Iberica S.L.U. in La Almunia de Doña Godina, Spain, seeks a QA Compliance Lead to ensure GMP-aligned quality systems, support inspections, supplier oversight, and continuous improvement across the site.

You will collaborate across teams to maintain inspection readiness, execute the Site Quality Plan, and manage data integrity and regulatory compliance. The ideal candidate has a life-sciences degree, 4+ years in pharma compliance, and fluency in Spanish and