Job title职位名称: Supervisor of Quality Control CMO

• Location工作地点： BEIJING

About the job工作职责

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. Your job, as Supervisor of Quality Control CMO within our M&S China-BEI Site, will be to making best class medicines with excellent strategies and tools and delivering them to our patients.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities职责描述：

Please indicate here the main job responsibilities请列举该职位的主要工作职责。

1.    Quality Control Management:

• Extend QC lab and build its analytical capability for entrusted product (biologics) release testing covering from raw materials, excipients, intermediates (API), and finished goods leveraging current QC capabilities.
• Supervise and coordinate quality control activities for CMO (biologics) production.
• Implement, and maintain quality control procedures and protocols.
• Ensure compliance with GMP, company policies, and regulatory requirements.

2.    Team Leadership:

• Manage, train, and mentor quality control team members.
• Assign tasks, monitor performance, and provide feedback to team members.
• Foster a culture of continuous improvement and quality excellence.

3.    Technical Expertise:

• Oversee and perform complex analytical testing of biologics (e.g. bioassay and function testing, Glycosylation analysis, physicochemical characterization …, etc).
• Interpret test results and make decisions on product quality and release.
• Troubleshoot and resolve quality-related issues in the production process.

4.    Documentation and Reporting:

• Ensure accurate and timely documentation of all quality control activities.
• Prepare and review batch records, test results, and quality reports.
• Maintain up-to-date standard operating procedures (SOPs) for quality control processes.

5.    Regulatory Compliance:

• Stay informed about relevant regulations and guidelines in the biopharmaceutical industry.
• Participate in regulatory inspections and audits.
• Contribute to the preparation of regulatory submissions related to quality control.

6.    Continuous Improvement:

• Identify opportunities for process improvements and cost reductions.
• Implement new technologies and methodologies to enhance quality control efficiency.
• Collaborate with other departments to optimize production and quality processes.…

About you 任职资格:

List here ideally the must-haves criteria to be successful on the role.

请列出胜任该职位所必须具备的条件。

• Experience:

工作经验:

• Minimum of 5 years of experience in quality control within the biopharmaceutical industry, with at least 2 years in a supervisory role.
• In-depth knowledge of GMP regulations and quality control processes for biologics .
• Proficiency in quality management systems and relevant software applications.

• Soft skill:

通用技能:

• Strong analytical and problem-solving skills.
• Excellent leadership and communication abilities.

• Technical skill:

专业技能:

• Proficiency in using HPLC (RP-HPLC, IEX,SEC, …, etc )for identity, purity, impurities of biologics
• Expertise in Capillary Electrophoresis (CE) molecular variants and impurities.
• Expertise in Cell-Based Assays and functions testing of biologics.
• Expertise in data Analysis and Interpretation, i.e. Statistical Analysis of QC data to identify trends and deviations and using QC software and data analysis tools effectively.

• Education:

教育背景:

• Bachelor's degree in Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related field. Advanced degree (MS or PhD) preferred.

• Languages:

语言要求:

Proficiency in English, oral and written

• Play to Win Behaviors: Stretch; Take Action; Act for Patients & Customers; Think One Sanofi

全力致胜行为: 超越自我, 主动出击, 以患者和客户为本, 团结一致

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.

Pursue Progress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
 

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!