全球质量审计师
Global Quality Auditor
**职位名称**: 全球质量审计员
- **工作地点**: 美国境内远程办公
**职位简介**
加入一个推动赛诺菲无缝、有目的且规模化交付的全球网络。在制造与供应领域，您将帮助重新构想改变生命的治疗方案如何更快地惠及全球人们。
**关于赛诺菲**:
我们是一家以研发为驱动、由人工智能赋能的生物制药公司，致力于改善人们的生活并实现引人注目的增长。我们对免疫系统的深入理解以及创新的产品管线使我们能够发明治疗和保护数百万全球人民的药物和疫苗。我们共同追寻科学的奇迹，以改善人们的生活。
**主要职责**
- 覆盖所有GXP审计，包括现行的良好的临床实践（GCP）和良好的药物警戒实践（GVP）。
- 根据赛诺菲流程，担任主审计师或联合审计师。
- 进行跨职能评估。
- 参与团队排班，并审核/批准团队成员的审计报告。
- 评估实体风险，制定有针对性的风险导向计划和/或提供缓解建议。
- 上报关键问题和风险。
- 审批/管理纠正和预防措施（CAPAs）。
- 在需要时进行尽职调查评估。
- 参与与其他赛诺菲质量审计、检查、情报与倡导团队的审计和活动。
- 可能参与部门QMS的创建，如培训课程、标准审计议程和受控文件。
- 行动自由度：高度独立，富有创造力，具有深思熟虑的风险承担意识和合规思维。
- 角色影响：能够发现不断变化的趋势，从而调整赛诺菲的审计和检查策略和战术。在转变赛诺菲审计实践方面发挥关键作用。
- 范围：赛诺菲全球质量组织、国家组织以及赛诺菲以外的第三方（如战略供应商等）。
**关于您**
基本要求：
- 药学、生命科学、工程或相关专业的学士或硕士学位，但接受所有专业背景。
- 至少5年以上GxP领域、良好药物警戒实践或良好临床实践的丰富经验。
优先考虑：
- 对全球监管要求和标准有深入了解。
- 对质量管理体系（QMS）有扎实的理解。
- 领导能力：能够领导跨职能团队和项目
- 风险评估：在评估和减轻质量风险方面有专长
查看英文原文
**Job Title: Global Quality Auditor**
- Grade: L3-2
- Hiring Manager: Zahra Brahimi
- Location: Morristown, NJ
**About the Job:**
Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
**About Sanofi:**
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.
**Main Responsibilities:**
- Covers all GXP audit in areas of current, Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP).
- Acts as a lead auditor or co-auditor, in accordance with Sanofi processes.
- Conducts transversal assessments.
- Contributes to team scheduling and reviews/approves audit reports for team members.
- Evaluates entity risks developing targeted risk-based agendas and/or advise on mitigations.
- Escalates critical issues and risks.
- Approves / manages CAPAs.
- Performs due diligence assessments, as/when needed.
- Participates in audits and activities with other teams in Sanofi Quality Audit, Inspection, Intelligence & Advocacy.
- May contribute to the creation of departmental QMS such as Training Curriculum, standard audit agendas, and controlled documents.
- Latitude of action: Highly independent, creative with thoughtful risk taking and compliance mindset.
- Role impact: Able to detect evolving trends which will result in adjustment of Sanofi audit and inspection strategy and tactics. Plays a key role in transforming the practice of auditing in Sanofi.
- Scope: Global Quality organizations in Sanofi, country organization, and third parties outside of Sanofi (e.g. Strategic Vendors, etc.)
**About You:**
Basic Qualifications:
- BS or BA degree in Pharmacy, Life Sciences, Engineering, or related, but will consider all degrees.
- Minimum 5+ years of extensive experience in GxP domains, Good Pharmacovigilance Practices, or Good Clinical Practices.
Preferred Qualifications:
- Deep knowledge of global regulatory requirements and standards.
- Strong understanding of quality management systems (QMS).
- Leadership Skills: Ability to lead cross-functional teams and initiatives
- Risk Assessment: Expertise in evaluating and mitigating quality risks
- Communication: Excellent written and verbal communication skills
- Independence: Highly independent with creative problem-solving abilities
- Compliance Mindset: Strong ethical foundation with thoughtful risk-taking approach
- Adaptability: Ability to detect evolving trends and adjust strategies accordingly
**Why choose us?**
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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## Pursue _progress_, discover _extraordinary_
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click [here](https://cscontactus.sanofi.us/accessibilityQuestionComments.aspx)
_US and Puerto Rico Residents Only_
Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
_North America Applicants Only_
The salary range for this position is:
$133,500.00 - $192,833.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fbenefits.sanofiusallwell.com%2Ffleet%2Fpublic%2Findex%2Fba511bf8-5c32-4828-9861-ab985fffab90%2F%3Fcid%3Dsanofi&data=05%7C02%7CMuhammad.Khanzada2%40sanofi.com%7C58d63db42fae425c386708def782ce2c%7Caca3c8d6aa714e1aa10e03572fc58c0b%7C0%7C0%7C639220338481842237%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=LopUyoJYYVCvnMzJTEf9BHYbvQ8GN4nYq%2FfpZh%2BR8DM%3D&reserved=0)