How would you like to be a key part of Global Auditing at Novartis, building upon and maintaining our exceptional standards? We are seeking talented professionals across Spain! This position offers flexible location options and can be based in Madrid or Barcelona.
In this role, you will lead, support, and report on independent GMP audits according to the Novartis Quality System and current GMP regulations to assess compliance with applicable standards, regulations, and guidance documents. You will review and approve corrective action plans in support of audit observations. The audits include internal and external targets such as manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers.
The Global GMP Senior Quality Auditor ensures alignment with the company's strategic direction, drives implementation of applicable actions, and provides consultation to Novartis business units through risk-based assessments.
About the Role
This role requires up to 60% travel.
Major accountabilities:
1. Support the development of an effective global risk-based audit strategy and program, incorporating input into the audit plan.
2. Plan, lead, conduct, document, and follow-up on GMP audits in accordance with Novartis Quality procedures and applicable regulations and standards.
3. Perform complex and higher-risk audits, including sterile API, aseptic DP, and combination products. Assess risk effectively and provide technical guidance, mentoring, and training.
4. Provide regulatory guidance for timely remediation and evaluate the acceptability of proposed filings.
5. Prepare audit reports per NVS requirements and timelines. Share best practices and lessons learned to support GMP auditor development and training. Mentor junior staff and act as a GMP compliance consultant for trainings and continuous improvement projects.
6. Ensure proper escalation of critical findings and support immediate follow-up measures. Define and record mitigation plans when applicable.
7. Assess responses (CAPA plans) to audit findings in collaboration with QA stakeholders and auditees.
8. Review and advise on policies and procedures. Stay current with regulations, standards, and guidance documents.
9. Require at least 12 years of broad experience in the Pharmaceutical or Medical Device Industry, with 3 years of auditing experience preferred. Must have excellent knowledge of regulatory requirements and sound judgment in their application.
10. Operational experience should include QA/QC management, manufacturing, development, or relevant regulatory authority work.
11. Expertise in at least one area such as DP Manufacturing, Laboratory activities, Medical Devices, API, Biologics, Microbiology, Computer System Validation, Quality Systems, Cell & Gene therapy, Radioligand therapy, or Sterile & Aseptic manufacturing.
12. Strong interpersonal skills, including diplomacy and persuasion, to foster cooperation and consensus among colleagues, vendors, and customers.
13. Ability to independently manage and evaluate complex compliance issues with minimal supervision.
14. Fluent in English, both written and spoken; additional languages are a plus.
15. Experience with local and international Health Authorities is advantageous.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives. Our vision is to become the most valued and trusted medicines company worldwide. Achieving this depends on our people. Join us and be part of this mission!
Benefits: You can find details about our benefits and rewards in the Novartis Life Handbook. We are committed to diversity and inclusion, fostering an outstanding, inclusive work environment with a diverse team that reflects the patients and communities we serve.
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