Lan Yu Email & Phone Number

Singapore

- GCP Quality Assurance Managemento Provide GCP quality expertise and input to secure regulatory compliance.o Perform GCP quality management and oversight activities: GCP audit, protocol deviation review & assessment, clinical documents quality & compliance review.- QMS Project Management for ISO 9001 Certificationo Lead and implement QMS initiative across drug discovery and development organisation.o Implement quality processes to meet ISO 9001 quality management system requirements.o Planned ISO 9001 certification activities and successfully obtained ISO 9001:2015 certification.- Quality System and Training Managemento Planned and implemented a FDA compliant quality system to manage QMS and controlled documentso Implemented training management systems and responsible for the organisation's training management activities.

北京

Outsourced to Roche as CPTS Advisor (Compliance, Processes, Trainings & Systems)- GCP inspections management to support NDA approval.- GCP quality managemento Conducted onsite visits, provided insight for site quality assessment & quality reporting.o Conducted quality review and assessment for HGRAC related activities, identified inconsistencies, proposed for issue resolution and instructed on process improvement.o Delivered GCP compliance, process, system, and training activities to ensure the country clinical operations team and strategic partnership meet business needs and study goals.o Established effective partnership with local medical affairs function, including responsibility for NIS, IIS study related process support. o Conducted document alignment between global processes and local processes to ensure compliance consistency in QSD (Quality System Documents).

北京

o GCP Audit Management: was responsible for functional audit management and oversight, including audit strategy and annual planning activities. o Responsible for and lead 21 GCP & GLP audits within a year covering China, US, and Japan. Such audits encompass audit related planning, report writing and CAPA management. o Audit and Inspection process implementation: led the audit, inspection, self-inspection process writing and provided guidance training. Established standards/SOPs and related supplements for quality department.o GCP Quality Improvement: analyzed and assessed quality finding via Quarterly Quality Report & Annual Quality Report, reported quality overview and trends to top management; and provided GCP training for lessons learnt, issue management and risk management.o QMS set up: led a working group to establish the quality process structure for QA, Clinical Operations, Medical Affairs and Regulatory Affairs function. Oversaw and facilitated the process writing, implementation.

Beijing

- Inspection Support: provided quality expertise in inspection preparation team, facilitated inspection preparation, including onsite self-inspection and issue follow up, onsite support in coordinating inspectors’ requests with onsite supporting team; ensuring post-inspection response coordination and management.o Lead Visanne (Dienogest) 2mg inspection for Phase I study: approved by CFDA in Dec. 2018.o Initiated Adempas (Riociguat) inspection activities for Phase I study.- GCP Process Improvement: supported process update in global working group, ensured process update were properly notified and trainings were assigned properly; supported regional-specific process development and implementation.- Led CAPA Management and Regional Support for Risk Management activities.- Acted as quality systems superuser for Learning Management System (LMS), Clinical Trial Management System (CTMS), Quality Management System (QMS); solved system queries and provided guidance for global function.- Newcomers’ Orientation Program & Training: was responsible for newcomers’ onboarding introduction & orientation training for process and quality systems. Developed a comprehensive Newcomer Manual to support the onboard process; provided continuous support on process, quality system related questions to new hires.

Bayer Center, East 3Rd Ring Road, Chaoyang District, Beijing

- Supported Head CP (Clinical Pharmacology) Asia in managing all administrative and business subjects:o Meeting arrangements: was responsible for all meeting arrangement, including Phase I conferences, facilitated and consolidated meeting minutes.o Travel arrangements.- Supported CP Asia colleagues for daily work and facilitated smooth communication between different stakeholderso Daily administrative work, including meeting and travel management, etc.o Enhanced communication and ensured effective information flow within CP Asiao Organized cross-function workshops & team building activities with Biostatistics, Regulatory etc. to improve cross-function collaboration.

Internal and External coordination:Follow-up and coordinate the cultural programs; Strengthen the relationship with clients;Do the preparation for all the cultural programs and follow up its implementation and collect feedback; prepare the presentations for the lectures;Cultural program interpretation.Marketing: Join INN (International Newcomers’ Network) monthly meeting and Expat Show; maintain a good relationship with partners and clients.Work out proposals for companies, embassies and international schools in Beijing;Coordinate with foreigners from different countries; collect clients feedback to inform event development.

Beijing & Huaibei

English teacherFully prepared before class, in accordance with the relevant requirements of complete lesson plans-writing;Communicate with parents about kids' learning process;Summarize students learning process, Analyze curriculum development and research;Tutoring students according to students’ situation;Perform other tasks given by the department leader.

研究生院同等学力, 企业管理/项目管理

Bachelor, English