17 Apr
Senior Clinical Quality Consultant
California, San diego , 92101 San diego USA

Vacancy expired!

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

Vacancy expired!


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