CQA团队负责人
CQA Team Leader
**职位名称**: CQA团队主管
**工作地点**: 远程，美国
**职位简介**
CQA团队主管（CQA TM）直接负责审计团队的管理与监督，主要职责是确保团队成员的培训、指导、激励和发展。CQA TM带领并激励团队成员发挥最大潜能，提升表现和整体价值。通过这些工作，TM确保临床项目通过独立的临床审计评估、检查管理、质量审查和与审计及检查活动相关的GCP建议得到充分支持，确保审计活动有效开展，并持续改进质量标准以满足监管要求。
该职位向临床质量评估主管汇报，并是该小组管理团队的活跃成员。
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我们是一家以研发为导向、由AI驱动的生物制药公司，致力于改善人们的生活并实现有吸引力的增长。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全球数百万人的药物和疫苗。我们共同追寻科学的奇迹，以改善人们的生活。
**主要职责：**
**战略风险导向审计**
- 监督团队成员的日常表现，确保在ICH/GCP、相关监管要求以及全球、部门和地域的QDs、政策和指南方面的适当指导和培训。
- 直接管理其团队和业务支持人员，包括目标与绩效管理、个人发展、行政事务以及必要的招聘。作为管理团队的一部分，参与制定部门年度目标和任务。
- 直接领导并积极参与审计计划，主动参与年度日程安排和审计策略的定期修订。
- 与CQA管理团队合作，参与政策、程序、指南和其他标准的制定、审核和更新，并确保其在团队内的实施。
- 确保计划审计的适当执行，并确保其团队内审计工作的有效开展。
查看英文原文
**Job title**:CQA Team Leader
**Location**: Remote, US
**About the job**
The CQA Team Manager (CQA TM) has direct management and supervisory responsibility of a team of auditors and is primarily responsible for ensuring the training, coaching, motivation and development of the individuals in his / her team. The CQA TM leads and inspires them to maximize their capabilities, performance and overall utility. By doing this the TM ensures that clinical projects are properly supported through independent clinical audit assessments, inspection management, quality reviews and GCP advice in relation to audit and inspection activities, that audit activities are effectively conducted, and ensures continuous improvement of the quality standards to meet regulatory requirements.
This position reports to the Head of Clinical Quality Assessment and is an active member of the management team for the group.
Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
**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 people’s lives.
**Main responsibilities:**
**Strategic Risk Based Audits**
- Oversees day-to-day performance of individuals ensuring appropriate coaching and training on ICH/GCP, relevant regulatory requirements and global, departmental and geographical QDs, policies and guidelines.
- Directly manages his/her team and business support staff, including objectives & performance management, individual development, administrative matters, and hiring as necessary. As part of the management team participates in the development of annual goals and objectives of the department.
- Directly leads and plays a key role in audit planning, actively participates in the development of the annual schedules and regular revisions of audit strategies.
- In collaboration with CQA Management team, contributes to the development, review and updates of the policies, procedures, guidelines and other standards, and ensures their implementation within his/her team
- Ensures appropriate implementation of planned audits and ensures his/her team resources are put to optimum use for all types of audits assigned, and ensures that skills are developed at team level.
- Responsible for the quality of the audits conducted by his/her team, including adequate conduct, reporting and follow-up of the audit activities as per departmental procedures, guidelines, etc. Ensures a quality driven risk-based approach to audit scope and reviews.
- Ensures the contribution of all members of his/her team to support key customers and provide GCP consultation in relation to audits and inspections, regulation interpretation and input / communication on functional or cross functional procedures. This includes support to internal and external clients for activities that support continuous improvement cycle such as Quality Reviews, participation in workgroups, etc.
- Participates in audits as needed with emphasis on complex objectives and/or as part of audit staff coaching, training, and assessment. During Investigator site audits, CQA Team Manager has direct access to subject individual data for records review and may have access to unblinded information/data. He/she is bound by professional secrecy and as such will not disclose any individual identity and/or individual medical information.
- Utilize predictive analytics and real-time data insights to identify potential risks and opportunities associated with clinical trials. Asses and escalate those risks as needed.
- Leader in determining the needs and designing the associated strategy for assessing audit and inspection quality trends / alerts via Transversal Quality Reviews (service provider / process). Ensure assignment of appropriate resources for the development and delivery of Quality Reviews to functions and leadership teams.
- Under Head of CQA oversight, coordinates and supports the control and follow-up of outsourced / contracted GCP assessment activities.
_**Inspection Activities:**_
- Leader in coordination and support and/or directly participates in the inspection activities by regulatory / compliance monitoring authorities. Will hold leadership roles such as Inspector facing host, backroom manager, and QC lead.
- Lead and coach team members in:
- the coordination and management of pre-inspection preparation visits,
- providing support to the inspection conduct,
- hosting site level inspections,
- overseeing post regulatory inspection follow-up activities.
**_Process Optimization :_**
- Apply critical thinking to develop and implement data quality control measures, leveraging AI and machine learning for enhanced accuracy.
- Participate in streamlined digital workflows that reduce manual processes and enhance operational efficiency
- Participate in the development of quality documents, digital tools and processes to enhance efficiencies.
_**Basic Qualifications**_
- Bachelor's degree in Life Sciences, Medical Sciences, Natural Sciences, or a related scientific discipline, or equivalent experience.
- Minimum 10 years of relevant experience with a bachelor's degree, or 5 years of relevant experience with an advanced degree.
- Minimum 5 years of Clinical Quality Assessment experience and/or experience in Clinical Trials, including Monitoring or Clinical Trial Management, with a demonstrated track record of strong performance.
- Extensive working knowledge of international regulations/Guidelines/Good Practices pertaining to the clinical domain.
- Good working knowledge of standard computerized software.
- Good business communication skills in English (orally / in riting)
- General management experience with technical / scientific staff
- Demonstrated knowledge in digital transformation and agile methodologies.
_**Key Competencies**_
- Proficient in clinical trial management systems, data visualization tools, and digital collaboration platform.
- Ability to translate data into actionable insights and strategic recommendations. Be organized and autonomous in decision making.
- Ability to communicate clearly, and effectively, to foster a productive dialogue and to do so across multi-cultural environments and in complex and/or sensitive situations.
- Effective people management and leadership skills, including the ability to serve as a change agent.
- Ability to work as a team builder, listening, promoting exchanges, mentoring and coaching. Motivating a team to support decisions and directions in times of change.
_**Technical Skills**_
- Expertise in clinical trial management systems and eClinical platforms
- Proficiency in data visualization and analytics tools
- Understanding of digital health technologies and their application in clinical trials
- In depth working knowledge of current regulations, guidelines and good practices pertaining to clinical development.
**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.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.
- Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs.
- 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.
- Join our Clinical Quality Assessment team and contribute to ensuring the quality of our clinical trials, through a risk-based and digital approach, and help accelerate medical breakthroughs
Sanofi US Services 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.
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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)