About the Role
Key Responsibilities
• Plan, lead, and execute GMP audits across global operations and external partners.
• Assess compliance with regulations, quality standards, procedures, and guidance documents.
• Document audit observations, prepare reports, and communicate findings to stakeholders.
• Review and approve corrective and preventive action plans addressing audit findings.
• Provide expert guidance and training on audit activities.
• Escalate critical compliance issues and support timely mitigation activities when required.
• Maintain expertise in evolving regulations, industry standards, and quality expectations.
Essential Requirements
•Degree in Chemistry, Pharmacy, Biology, Engineering, or another related scientific discipline; other degrees with relevant experience may be considered.
•Minimum 10 years of broad experience in the pharmaceutical or medical device industry, including QA/QC management and manufacturing, development, or other relevant experience such as working at a regulatory health authority.
•Expertise in at least one of the following areas: drug product (DP) manufacturing, biologics, sterile manufacturing, laboratories, microbiology, packaging, active pharmaceutical ingredients (API), excipients, medical devices, computer system validation, or quality systems.
•Excellent knowledge of regulatory requirements, with experience and/or interaction with local Health Authorities and sporadically with other Health Authorities; sound and practical judgement in the interpretation and application of regulations and standards.
•Strong interpersonal skills, including diplomacy, persuasion, and stakeholder management.
•Willingness to travel approximately 60% globally.
•Advanced oral and written English communication skills.
Desirable Requirements
• 3 years auditing experience
• Proficiency in an additional language such as German, French, Italian, Chinese, or Spanish.
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Role Requirements
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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