GMP QA Compliance Lead — Inspection Readiness & QMS

Novartis AG; Zaragoza; On-site; EUR 45,000 - 84,000; Full time

Benefits offered by this job

Hybrid working options

14 weeks parental leave

Job summary

Novartis AG in Zaragoza, Spain, is seeking a QA Compliance Lead for our La Almunia site. You will strengthen compliance with GMP, lead inspection readiness, and oversee quality systems, supplier quality, and CAPA programs to protect patients and ensure product quality.

We require a life-science degree and at least four years in pharmaceutical compliance, with fluent Spanish and English, and strong collaboration across functions.

Qualifications

• 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.
• Strong knowledge of Good Manufacturing Practice, Good Clinical Practice and Pharmacovigilance requirements.
• Solid understanding of regulatory Quality Systems requirements within a pharmaceutical environment.
• Strong knowledge of risk assessment and risk management principles and tools.
• Fluent written and spoken Spanish and English, with strong communication and collaboration skills.

Responsibilities

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

Skills

GxP knowledge

Risk management

Regulatory compliance

Spanish language

English language

Communication skills

Quality investigations

Education

Bachelor's degree in Pharmacy

Job description

Novartis AG in Zaragoza, Spain, is seeking a QA Compliance Lead for our La Almunia site. You will strengthen compliance with GMP, lead inspection readiness, and oversee quality systems, supplier quality, and CAPA programs to protect patients and ensure product quality.

We require a life-science degree and at least four years in pharmaceutical compliance, with fluent Spanish and English, and strong collaboration across functions.