Associate Director, Regional Clinical Compliance

General Description: Adopt and implement the global and regional clinical compliance activities planning and implementation within the scope of the assignment. Optimize operation process, assist global and regional clinical operational team in improving compliance with GCP, SOPs, and applicable regulatory requirements and guidelines. Provide advice and support relevant key stakeholders about quality compliance. Lead or initiate the creation, revision and optimization of regional quality management documents, local SOPs/WI or applicable guidance. Strategy planning and execution of clinical compliance at regional level to meet business demand and company development. Essential Functions of the Job: Contribute to overall Clinical Operations quality strategy and performance against key metrics. Oversee regional and site quality by planning and conducting all types of quality visits and other related tasks, as well as managing consultations. Drive or support in regional operation process optimization, creation, revision of regional quality management documents, SOPs/WI or applicable guidance. Support global and regional clinical operational team in improving compliance with GCP, SOPs, and applicable regulatory requirements and guidelines. Work with the operational team, quality assurance & inspection management team to manage quality issues to support inspection readiness. Provide support to CST for audits, including audit report responses and guidance to operational staff in risk assessment, risk management, and CAPA plan. Oversee regional clinical compliance team to support site inspection conduct for all inspection related visits, e.g.，Inspection Preparation Visit (IPV), Spring IPV, IR on-site visit, completion of assigned inspection support within clinical operation team and completing relevant quality activities. Oversee or lead team to ensure quality trend analysis, lessons learned with global and regional operational team and task force, or specific quality improvement initiatives if applicable. Oversee or lead training delivery to GCO team and drive study team’s enhancement in quality management skills if applicable. Computer Skills: Meet with daily work needs Other Qualifications: 8 years or above of progressive experience in clinical research or clinical operations within the biotech, pharmaceutical, CRO, or relevant field; Exhibits a strong understanding of methodologies and approaches; Documented training, knowledge, and application of current FDA Regulations, GCP, and ICH guidelines in clinical trials required; Regulatory authority inspection experience preferred; Strong written and verbal communication skills; Fluent English: oral and written. Travel: Based on business request, expectation of 30%-50% travel 百济神州全球胜任力 当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. ●Fosters Teamwork ●Provides and Solicits Honest and Actionable Feedback ●Self-Awareness ●Acts Inclusively ●Demonstrates Initiative ●Entrepreneurial Mindset ●Continuous Learning ●Embraces Change ●Results-Oriented ●Analytical Thinking/Data Analysis ●Financial Excellence ●Communicates with Clarity 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. Due to the reasonable business need for human resource management as a result of BeOne’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeOne Job Applicant Privacy Policy (BeOne official website - Privacy Policy - Job Applicant Privacy Policy). If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeOne Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.