Senior Global GMP Quality Auditor

About the role

Novartis is looking for a Senior Global GMP Quality Auditor to lead, support and report independent GMP audits under the Novartis Quality System and current GMP regulations. The role involves travelling up to 60% of the time and can be based in Spain (Madrid or Barcelona) or Slovenia (Ljubljana); relocation support is offered. Audits cover manufacturing sites, development centres, quality systems, contract manufacturers, laboratories, warehouses, country organisations and suppliers, including high-risk areas such as sterile APIs, aseptic drug products and combination products.

Key responsibilities

• Support the development of a global risk-based audit strategy and plan, and collect input into it
• Plan, lead, conduct, document and follow up GMP audits in line with Novartis quality procedures and applicable regulations, standards and guidance
• Provide technical guidance, mentoring and training on audit activities, and mentor junior GMP staff
• Prepare audit reports and identify best practices and lessons learned
• Review and approve corrective action plans and assess the adequacy of CAPA responses with the QA representative and auditee
• Escalate critical findings to management and ensure follow-up and mitigation plans are recorded
• Advise on policies and procedures and maintain current knowledge of regulations and standards

Required profile

• 12+ years of experience in the pharmaceutical or medical device industry; 3 years of auditing experience preferred
• Strong knowledge of GMP regulations and practical judgement in applying them
• Operational experience including QA/QC management, manufacturing, development or a regulatory health authority
• Strong experience in sterile operations and/or expertise in at least one of: DP manufacturing, laboratories, medical devices, API, biologics, microbiology, computer system validation, quality systems, cell and gene therapy or radioligand therapy
• Fluent English, written and spoken; other languages are a plus

Required skills

• GMP and cGMP compliance
• Quality management systems (QMS)
• Internal auditing and data integrity
• Regulatory compliance

What we offer

• Expected annual base salary of EUR 69,100 to 128,300, depending on skills, competencies and experience
• Possible performance-based bonus
• Flexible and hybrid working options where possible
• Minimum of 14 weeks paid parental leave
• Insurance plans, retirement plans and wellbeing resources