质量审计

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role: 

We're seeking highly motivated and self-starting individuals to join our diverse and very engaged quality auditing team! We offer a quality auditing function, with good visibility into our Research & Development function and close interaction with various stakeholders. In this role you lead, coordinate, or participate in the organization and execution of quality audits of different audit types (Investigator site audits, vendor audits (CROs, Phase I Facilities, central laboratories), process and study audits) within our company. Your responsibilities include scoping, audit conduct, coordination, communication of audit results and action planning. You prepare a meaningful scope, standardized audit agenda’s/plan’s, create audit reports, and present audit observations as well as collect audit responses. Further, taking over individual special projects to support the continuous improvement of the quality auditing function and support in local regulatory and Mock Inspection.
 

Who you are:

• Minimum 5 years QA/GCP auditing experience or relevant professional experience in international clinical and/or biotech industry, in particular clinical quality management, clinical development, or regulatory compliance with a minimum of 3 years in Clinical Quality Assurance
• Deep knowledge in conducting Quality Assurance audits of global and local Phase I – IV clinical studies at Clinical Investigator sites to ensure compliance of study management with applicable ICH guidelines, local and international regulations as well as Company internal policies/procedures and study protocols
• Comprehensive demonstrated working knowledge of principles and concepts related to Quality Assurance – including Risk-Based Quality.
• Wide range of auditing skills covering a broad range of GCP areas and/or specialized auditing skills (=Subject Matter Expert).
• In-depth knowledge of GCP guidelines and applicable regulations; working knowledge in other GxP disciplines such as GVP is desirable.
• Strong ability to work in a structured way: good planning, project management and organization skills and having a service-minded but goal-oriented mindset
• Team player with very good intercultural and excellent communication skills; independent, motivated, responsible approach to work 
• User knowledge in MS Office 365, Veeva Vault QMS, Power BI or similar software
• Excellent oral and written communication skills in English is key
• Willingness to travel domestic & international (up to 20-30% travel time)
• Location: Beijing or Shanghai 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!