Danaher Corporation Clinical Quality Manager in Shanghai, China
The primary responsibilities for the Clinical Quality Manager include:
Plan, implement and manage China Clinical Affairs (CA) team Quality and Compliance activities which includes annual internal audit plan, QMS update, risk management to assist CA team to deliver quality & compliance activities with relevant ICH, GCP, country regulations and guidelines.
Conduct co-monitoring, internal audit per QC plan, mentor and coach CRA when applicable.
Support CA team in preparing for BSI audit and NMPA inspection and provide input into the generation of timely and appropriate audit or inspection response plans, gap analysis, countermeasure.
Provide compliance support by answering questions or providing advice on GCP, SOPs, regulations and guidelines and bring issues to the attention of CA management team as appropriate.
Lead China CA QMS improvement activities, Drives sustainment & improvement of CA functional standard work.
Contribute to the development of and responsible for implementation and delivery of specific initiatives as defined and agreed upon.
Work as the project manager and faculty to conduct instructor-led training to China CA team on GCP, SOPs and related regulations or guidelines.
Review, revise, write and implement, as required, CA SOPs.
Keep effective communication cross functionally and geographically.
Lead and Identify the appropriate DBS tools to solve complex issues, utilize DBS to drive process improvement (i.e. creating SW, leading Kaizen, leading DM, leading PSP), manage risks, and propose the appropriate countermeasures
Minimum of 3 years related experience in clinical trial management or related areas including at least 2-year experience in Clinical Operations and 1 year experience in Quality Control or Quality Assurance is preferred.
Good understanding of IVD clinical trials quality control principles, clinical monitoring procedures, all relevant GCP guidelines and of local and international regulations.
Knowledge of medical terminology and high proficiency in Microsoft Word / Excel / PowerPoint / Outlook
Excellent, interpersonal, communication and organizational skills.
Good team player, self-motivated and attention to details.
Strong customer focused sensitivity towards internal and external customers.
Competent in written and oral English.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.