?BA/BS degree required
advanced degree preferred.
?Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.
?Minimum 7 years of GCP-related Quality Assurance or relevant clinical trial experience.
?Recent experience in leading and hosting NMPA/CFDI inspection and other health authority inspection experience with FDA, MHRA etc.
?Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development
?Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective action plans that mitigate risks to the company, patient safety and data integrity.
?Collaborative team player proficient in stakeholder management, possessing a positive attitude, critical thinking skills, and the ability to swiftly identify creative solutions to complex problems
?Strong technical writing skills
able to write quality positions, audit reports, and procedures.
?Excellent communication skills with ability to negotiate and influence without authority in a matrix environment
?Strong judgment, project management, and decision-making skills
able to manage multiple projects and demanding timelines
?Superior attention to detail and ability to analyze complex data
?Able to read Chinese and speak Mandarin fluently
?Able to travel to various meetings, inspections and/or audits, including overnight trips and international travel.
