QA Operations Lead: Elevate Sterile Quality & Compliance

Novartis; Zaragoza; Vor Ort; EUR 45.000 - 84.000; Vollzeit

Benefits dieser Stelle

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

14 weeks paid parental leave

Zusammenfassung

Novartis in Spain is seeking a Quality Assurance Operations Lead to ensure safe, compliant release of sterile injectables. You will lead QA Operations on site, driving continuous improvement and a strong quality culture across the site.

The role oversees GMP-compliant manufacturing support, regulatory alignment with EMA/AEMPS, and collaboration with Production, Quality Control, and Site Management to maintain inspection readiness.

Qualifikationen

• Scientific degree in Pharmacy, Chemistry, or Biology.
• 5+ years in the pharmaceutical industry.
• Strong knowledge of QA operations and quality requirements.
• Solid understanding of cGMP regulations and regulatory standards.
• Fluent in Spanish and English, both written and spoken.

Aufgaben

• Lead compliance with GMP, AEMPS, EMA and the Novartis Quality Manual.
• Oversee QA Operations: product release, documentation, SOP approvals.
• Ensure quality oversight of manufacturing, validation, cleaning and equipment.
• Manage QA processes: OOS, deviations, CAPA, complaints, recalls.
• Support audits, inspections, and annual product quality reviews.

Kenntnisse

QA Operations

cGMP knowledge

Regulatory compliance

Aseptic manufacturing

Team leadership

Ausbildung

Pharmacy, Chemistry, or Biology degree

Jobbeschreibung

Novartis in Spain is seeking a Quality Assurance Operations Lead to ensure safe, compliant release of sterile injectables. You will lead QA Operations on site, driving continuous improvement and a strong quality culture across the site.

The role oversees GMP-compliant manufacturing support, regulatory alignment with EMA/AEMPS, and collaboration with Production, Quality Control, and Site Management to maintain inspection readiness.