Senior Global GMP Quality Auditor

🔥 0 minutes ago

🌐 Spain, Slovenia – Remote

🇪🇸 Spain – Remote 🇸🇮 Slovenia – Remote

💵 €69.1k - €128.3k / year

⏰ Full Time

🟠 Senior

🔎 Auditor

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Novartis

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1996

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Novartis is an innovative medicines company dedicated to reimagining medicine to improve and extend people’s lives. With a presence in over 250 million patients worldwide, Novartis focuses on harnessing scientific breakthroughs to develop transformative, high-value treatments in areas such as cardiovascular, renal and metabolic diseases, immunology, neuroscience, and oncology. The company is committed to diversity, equity, and inclusion, and aims to create a positive impact through societal contributions and environmental sustainability efforts. Furthermore, Novartis engages in research collaborations and embraces modern technology platforms to advance their research and development capabilities, making them a leader in the global healthcare industry.

📋 Description

• Lead, support, and report independent GMP audits according to the Novartis Quality System and current GMP regulations • Assess compliance with applicable regulations, standards, and guidance documents • Review and approve corrective action plans supporting audit observations • Audit manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers • Support strategic development of a global risk-based audit strategy and program • Plan, lead, conduct, document, and follow up on GMP audits • Conduct complex and higher-risk audits involving sterile API, aseptic DP, and combination products • Provide technical guidance, mentoring, and training on audit activities • Provide regulatory guidance for remediation and recommendations regarding filing acceptability • Prepare audit reports according to Novartis requirements and timelines • Identify and report best practices and lessons learned • Act as a GMP compliance consultant for trainings, task forces, and continuous improvement projects • Escalate critical findings and support immediate follow-up measures • Define and record mitigation plans when applicable • Assess audit finding responses and CAPA plans with QA representatives and auditees • Review and advise on relevant policies and procedures • Maintain current knowledge of regulations, standards, and guidance documents

🎯 Requirements

• 12+ years broad experience in Pharmaceutical or Medical Device Industry • 3 years auditing experience preferred • Excellent knowledge of regulatory requirements • Strong knowledge of GMP regulations • Sound and practical judgement in interpreting and applying regulations and standards • Solid operational experience including QA/QC management and manufacturing, development, or other relevant experience such as working at a regulatory health authority • Strong experience in Sterile and/or expertise in at least one of: DP Manufacturing, Laboratories activities, Medical Devices, API, Biologics, Microbiology, Computer System Validation, Quality Systems, Cell&Gene therapy, Radioligand therapy • Strong interpersonal skills, including diplomacy and persuasion • Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision • Fluent English, written and spoken • Experience and/or interaction with local Health Authority and sporadically with other Health Authorities is a plus • Ability to work in Spain (Madrid or Barcelona) or Slovenia (Ljubljana) • Willingness to travel up to 60% of the time

🏖️ Benefits

• Relocation support • Insurance plans • Retirement plans • Wellbeing resources • Global recognition programs • Flexible and hybrid working options, where possible • Minimum of 14 weeks paid parental leave • Performance-based bonus eligibility • Global total rewards offering