Development Operations:

• Ensure adherence to GCP, GVP and overall quality as point of contact in China

• Support team in identifying, escalating and putting risk plans in place to mitigate risks.

• Support overall quality within China for all the on-going studies and submissions

• Support and coordinate in preparation for regulatory inspections and various audits in China (local partners, CROs, or other vendors, etc.)

• Work with teams to address quality issues with local partners & CROs and help teams bring them back in to compliance.

• Contribute and support facilitation, presentation and communication of lessons learned

• Derived proposals from Lessons Learn for process improvement

• Support in SOP gap analysis and ensure integration and alignment with global, and coordinate to develop local SOPs/WIs per need

Skills/qualification

• Broad knowledge in GCP, GVP and other local regulations

• Experience in QMS system establishment

• Experience with inspection/audit coordination

• Problem-solving and leadership to ensure continuous improvement

• High level of customer Service mindset and Team Player

• Adapt at identifying issues, driving to root cause and able to drive solutions

• Experience in managing complex and sensitive operational challenges

• Well developed and effective verbal and written communication skills used in working with peers and employees at all levels of the organization

• Acute attention to details

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com