Global GMP Senior Quality Auditor Lead
hace 2 semanas
We are seeking an experienced professional to lead our global quality assurance efforts, ensuring compliance with regulatory requirements and industry standards. This role involves conducting independent GMP audits, reviewing corrective action plans, and providing technical guidance to Novartis business units.
Key Responsibilities:
- Support the development of a strategic risk-based audit strategy and program.
- Plan, lead, and conduct GMP audits according to Novartis Quality procedures and applicable regulations.
- Provide regulatory guidance for timely remediation and recommendations regarding filing acceptability.
- Mentor junior staff and act as a GMP compliance consultant for trainings and task forces.
- Ensure adequate definition and recording of mitigation plans and assess the adequacy of responses to audit findings.
Requirements:
- At least 12 years of experience in the pharmaceutical or medical device industry, with 3 years of auditing experience preferred.
- Excellent knowledge of regulatory requirements and sound judgment in their interpretation and application.
- Operational experience in QA/QC management and manufacturing or development, or other relevant experience.
- Expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Biologics, Microbiology, Computer System Validation, Quality Systems, Cell&Gene therapy, Radioligand therapy, Sterile & Aseptic manufacturing.
- Strong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus.
- Ability to independently manage and objectively evaluate complex compliance issues.
- Fluent English, written and spoken, with other languages a plus.
Why Choose Novartis?
We are a leading healthcare company dedicated to reimaging medicine to improve and extend people's lives. Our associates drive us each day to reach our ambitions, making us a great place to work. Estimated salary for this position is €120,000 - €180,000 per year, depending on qualifications and experience.
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