How would you like to be a key part of the Global Auditing at Novartis, building upon and maintaining our exceptional standards? We pursue talented professionals across Spain! This position offers flexible location options 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. You will review and approve corrective action plans and conduct audits of 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, assists in implementing relevant actions, and provides consultation through risk-based assessments.About the Role
Travel requirement:
Up to 60% of the time.Major accountabilities include:
Develop and support a strategic, risk-based global audit program.Plan, lead, conduct, document, and follow up on GMP audits, including complex and high-risk areas such as sterile API and aseptic DP.Provide technical guidance, mentorship, and training.Offer regulatory guidance for timely remediation and assess acceptability of filings.Prepare audit reports, identify best practices, and mentor junior staff.Ensure proper escalation of critical findings and support follow-up actions.Assess responses to audit findings and review policies and procedures.Maintain knowledge of regulations, standards, and guidance documents.Qualifications:
At least 12 years of experience in the Pharmaceutical or Medical Device Industry, with 3 years in auditing preferred.Strong knowledge of regulatory requirements and practical judgment in their application.Operational experience in QA/QC management, manufacturing, development, or related fields.Expertise in areas such as DP Manufacturing, Laboratories, Medical Devices, API, Biologics, Microbiology, etc.Strong interpersonal skills and ability to manage complex compliance issues independently.Fluent in English;
additional languages are a plus.Why Novartis?
Our purpose is to reimagine medicine to improve lives. Join us to be part of this mission! Learn more:
https:
//www.Novartis.Com/about/strategy/people-and-cultureBenefits and Rewards:
Details available in the Novartis Life Handbook:
https:
//www.Novartis.Com/careers/benefits-rewardsDiversity and Inclusion:
We are committed to building an inclusive environment and diverse teams reflecting the communities we serve.Join our talent community to stay connected and learn about future opportunities:
https:
//talentnetwork.Novartis.Com/network
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