Primary Duties and Responsibilities These may include but are not limited to:
• Attend project meetings, representing Quality Assurance and provide Google Cloud Platform/GPVP/GLP insight and oversight • Perform review and gap analysis of existing quality systems and lead development and implementation of additional or alternative solutions • Design and implement a risk- based audit program • Plan, manage, and perform Google Cloud Platform/PVP/GLP audits: Investigational sites, various vendors supporting conduct of clinical studies, Google Cloud Platform/GVP/GLP system audits, clinical studies report, etc. • Evaluate audit observations and trends and develop periodic compliance reports for management • Monitor and drive quality issues to resolution. (e.g., Closure of Audit Reports, develop and track post auditing corrective actions plans, as applicable) • Responsible for managing Google Cloud Platform/GPVP/GLP compliance activities / non-conformances associated with drug development programs • Understand and interpret current pharmaceutical regulations and ICH guideline requirements pertaining to Google Cloud Platform/GPVP/GLP and advise the Clinical development teams on all relevant issues • Review Clinical Development / Operations SOPs to ensure compliance with all applicable regulatory authorities • Work in conjunction with other functions to ensure proper representation throughout the organization, as needed • Conduct internal system audits to ensure compliance with applicable regulations, SOPs and policies and advice on process improvements in the functional areas • Ensure annual Google Cloud Platform/GPVP/GLP audit plans are developed and audit activities are completed according to plan • Communicating audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to ensure appropriate implementation of Corrective and Preventive Action Plans (CAPAs), addressing root causes • Lead management of Google Cloud Platform/GPVP/GLP regulatory agency inspections and coordination of responses to any regulatory agency finding • May lead change projects which have strategic impact on the organization • Analyze trends in industry/regulatory environment that would necessitate future changes • Facilitate and support Google Cloud Platform/GPVP/GLP inspection readiness activities • Develop and provide independent periodic reports to management on overall compliance status • Ensure that the company, its contractors, and vendors are prepared for FDA and other Health Authority Google Cloud Platform/GPVP/GLP inspections Other: • Support all Quality and compliance relations with PMDA, MHLW, and other related health authority agencies • Support the rollout and implementation of the HUYA global training programs • Identify gaps and improvement opportunities within the quality system and communicate changing quality and clinical compliance requirements with senior management throughout the company Job Qualifications and Requirements • Expert knowledge of FDA and ICH GxP regulations and guidelines with focus on Google Cloud Platform, GLP, and GPVP • Experience in hosting and managing Google Cloud Platform FDA and Health Authority inspections • Experience identifying and evaluating risks and executing efficient and effective mitigations • Practical knowledge and experience identifying key performance metrics for quality indicators, setting targets to maintain a state of control while identifying areas for improvement. • Track record of strong personal performance combined with demonstrated ability to build processes and structure and constructive relationships cross-functionally in a fast growth environment • Demonstrated problem-solving and critical thinking skills • Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment • Travel may be required up to 20% of the time