Global GMP Quality Auditor
工作简介 地点：远程/墨西哥 （或加拿大，请参见 REQ-10082666）Novartis 不会为此角色提供搬迁支持。你是否热衷于维护质量和推动全球医疗保健组织持续改善？作为 Novartis 的全球 GMP 质量审计员，你将在确保我们全球网络中的合规性，质量和患者安全方面发挥关键作用。这是与各种制造场所，开发中心，合同制造商，实验室，仓库和供应商合作的机会，利用你的专业知识来识别风险，加强质量系统并影响积极变化。如果你在合作环境中勃发展，并且受到全球卫生保健方面有意义的影响的动机，我们鼓励你申请。工作描述 关键责任 · 在全球运营和外部伙伴之间规划，领导和执行 GMP 审计。·评估遵守法规，质量标准，程序和指导文件。·记录审计观察，准备报告并向利益相关者传达调查结果。·审查和批准针对审计结果的纠正和预防行动计划。·提供审计活动方面的指导和培训。·扩大重点问题，并在需要时支持适应措施。· 保持在不断变化的监管，行业标准和质量期望方面的专业知识。基本要求 · 化学，药品，生物，工程或其他相关科学学科学位；可考虑具有相关经验的其他学位。· 在制药或医疗器械行业至少有10年的广泛经验，包括 QA/QC 管理和生产，开发或在监管卫生机构工作等其他相关经验：· 至少在以下领域之一的专业知识：药品制造，生物学，无菌制造，实验室，微生物学，包装，活性药物成分 (API),辅助剂，医疗器械，计算机系统验证或质量系统。·具有监管要求的卓越知识，经历和/或与当地卫生当局以及其他卫生机构间往互动；在解释和应用法规和标准方面有健全和实际判断力。·强大的人际技能，包括外交，说服能力。
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Job Description Summary
Location: Remote/Mexico (or Remote/Canada for Canadian role, please see REQ-10082666)
Novartis will not offer relocation support for this role.
Are you passionate about safeguarding quality and driving continuous improvement across a global healthcare organization? As a Global GMP Quality Auditor at Novartis, you will play a critical role in ensuring compliance, quality, and patient safety across our global network. This is an opportunity to work with diverse manufacturing sites, development centers, contract manufacturers, laboratories, warehouses and suppliers, using your expertise to identify risks, strengthen quality systems, and influence positive change. If you thrive in a collaborative environment and are motivated by making a meaningful impact on healthcare around the world, we encourage you to apply.Job Description
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.
- Maintainexpertise 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.
Skills Desired
Collaboration, Data Integrity, Decision Making, Leadership, Risk ManagementOriginally posted on Himalayas