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Job Description

roles& responsibility :

Provides quality assurance oversight of the global and local clinical research programs in Research and Development (R&D), Plasma Derived Therapy (PDT), Vaccines Business Unit (VBU), Oncology Business Unit (OBU), and Global Medical Marketed Products Development (MPD) with the overall goal of inspection readiness.Serves as a Strategic Quality Thought Partner to Clinical Program Teams and other key stakeholders in the delivery of the clinical research programs, providing professional clinical research quality expertise and risk-based advice. Defines and implements a risk-based program audit strategy, ensuring the communication of significant quality and compliance risks to key stakeholders and Management, and ensuring appropriate and timely investigations and mitigations are in placeLeads the inspection readiness programs, the management of the inspection, and the response and follow-up activities. Ensures that inspection risks are well-communicated and mitigated for both sponsor and investigator site inspections.

R&D Qualifications & Skills

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 developmentAdvanced 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 problemsStrong 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 environmentStrong judgment, project management, and decision-making skills; able to manage multiple projects and demanding timelinesSuperior attention to detail and ability to analyze complex dataAble to read Chinese and speak Mandarin fluentlyAble to travel to various meetings, inspections and/or audits, including overnight trips and international travel.

 

LocationsShanghai, China

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time