QMS Lead

Department
部门

Medical Office, Research and Development
医学办公室,研发部
Title
职位

R&D QMS (Sr.Manager / AD)
研发质量体系高级经理/副总监

Starting Date
任职时间
Direct Report
直线经理

Quality Assurance Officer
质量保证负责人

Direct Subordinates
直接下属

R&D QA manager
质量保证经理

Primary Function
主要职能
  • The position served as the R&D QMS lead role who contribute to establish, implement, improve quality management system throughout I-Mab R&D organization to assure the compliance with GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GVP (Good Pharmacovigilance Practice), country specific regulations, and I-Mab Policies and Procedures.
  • This position will be a partnership with R&D QA officer and Sr management team who will be able to lead and drive QMS system effectively implementation into IMAB R&D globally, lead at least one audit type in one of the GXP area (internal &vendor audit is preferred). In addition, the role will dedicate to all R&D quality activities under R&D QA lead supervision including the execution of the I-Mab R&D QA strategy, development of R&D QA processes and procedures, participate in R&D QA goals and initiatives in line with the QMS implementation, and support regulatory authority inspections etc.
  • 致力于推动建立,实施和持续改进质量管理体系确保天境生物研发各项工作符合 GLP,GCP,GVP 的要求,符合地方性法律法规和天境生物内部政策和文件的规定。
  • 研发质量体系负责人将作为研发部中高层管理团队合伙人,能够领导和驱动质量管理体系有效的在全球研发各部门的实施,能够在 GXP 领域领导至少一种审计类型(如内部或供应商审计)。该职位还将致力于开展并推动各项在研发 QA 负责人授权下各项研发质量活动,包括执行落实执行天境生物研发各项质量保证政策,制定质量保证流程和文件,参与研发质量保证的目标和实施符合质量管理体系,并支持监管机构的视察等质量活动。
Major Responsibilities and Duties
主要职责和任务
  • A full partner with the R&D functional groups by establishing and maintaining a quality-oriented organization that assures sustainable compliance with the laws and regulations governing drug discovery and development as well as the validation of computer-based systems to regulatory standards.
  • Establish, maintain, standardize, and manage Quality Management System (QMS) covering all GxP activities and clinical studies.
  • Ensures that there is an appropriate and systematic approach in place for quality approval of documents such as Standard Operating Procedures, deviations, risk evaluation and management, validation and other quality related records as defined within the QMS.
  • Ensures regulatory requirements and I-Mab policies are implemented within SOPs as appropriate.
  • Provide Quality Assurance (QA) oversight of Discovery, Non-Clinical and Clinical Programs.
  • Serve as a subject matter expert for Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP) for Discovery/Non-Clinical/Clinical R&D Project Teams.
  • Support an internal/external audit program to verify and improve the effectiveness of the quality management system.
  • Lead multidisciplinary or cross-functional work/quality project and any quality initiatives, serve as part of strategic teams with in the group/ discipline.
  • Support the performance of the QMS via the agreed Quality Key Performance Indicators – to ensure deviation, Corrective Actions and Preventive Actions et al are handled to a high standard in appropriate timeframe.
  • Schedule and support Quality Management System Periodic Management Review.
  • Contribute to the preparation for and actions arising from inspections by Regulatory Authorities/Notified Bodies, serve as coordinator for onsite inspections.
  • Provide training/mentoring to the junior QA staff.
  • 与 R&D 各职能部门建立全面合作伙伴关系,致力于建立、维护质量导向的 R&D 组织。确保符合药物发现及开发相关法规以及计算机系统符合相关监管标准。
  • 建立、维护、标准化及管理涵盖所有 GXP 相关活动及临床研究的质量管理体系。
  • 确保合理的及系统性的质量保证机制批准 QMS 相关文件包括:标准操作流程、偏差、风险评估及管理文件、认证文件以及其他质量相关文件。
  • 确保相关的法规及天境生物的政策通过标准操作规程得到很好的执行。
  • 对早期发现,非临床及临床项目进行质量保证监督。
  • 作为 GCP, GLP 及 GVP 的相关问题合规专家为相关 R&D 早期发现/非临床/临床团队提供支持。
  • 支持建立及管理内部/外部审计计划以验证及改善质量管理体系的有效性。
  • 领导多学科或跨职能的工作/质量项目/质量举措,作为团队/学科战略团队的一部分。
  • 支持关键 QMS 质量指标的在研发各个关键领域的推动和实施,确保高质量及时的处理偏差、CAPA等。
  • 协助质量负责人完成领导管理层定期对质量管理系统进行评估。
  • 支持来自监管机构或第三方机构的稽查准备及相关行动,作为现场稽查的协调人。
  • 为初级QA员工提供培训及指导。
Qualifications
资格要求
  • B.S and/or M.S in chemistry, Biology, or Health related field.
  • Minimum 6years in pharmaceutical industry and/or non-clinical/clinical research or regulatory compliance experience.
  • Minimum 3 years in GLP/GCP/GMP Quality Assurance functional experience.
  • Knowledge of drug development processes and GXP regulations.
  • Proven experience and competency in regulatory inspection and audit program preparation ,management and related follow-up.
  • Project management capability: be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre- established goals and deadline.
  • Ability to influence and negotiate effective solutions within internal/external stakeholders.
  • Demonstrated ability to work both independently and in a team environment.
  • Demonstrated analytical, problem-solving and decision-making skills.
  • Ability to effectively negotiate with and influence project teams is preferred.
  • Strong verbal and written communication and stakeholder management skills.
  • Demonstrated ability to effectively organize, execute tasks and time management.
  • Fluency in written and spoken English required.
  • 本科或以上学历。
  • 至少6年制药领域、临床开发,或合规领域工经验和 GXP环境工作经验。
  • 至少3年GLP / GCP / GMP质量管理工作经验。
  • 熟知药物发展过程和GXP管理规定。
  • 具备监管检查和GXP审计计划准备、管理和相关跟踪的经验和能力。
  • 项目管理能力:能够管理复杂的任务/项目,及时有效地交付所有预期的交付成果,并在预先设定的 目标和期限内主动沟通变更。
  • 能够很好的协调和影响内部或与外部/内部的利益相关者达成有效解决方案。
  • 具备独立工作和团队协作能力。
  • 具备分析能力,问题解决能力和决策能力。
  • 期望拥有有效的谈判能力和对项目组的影响力。
  • 出色的口头和书面表达能力与利益相关方管理能力。
  • 具备有效组织能力和执行力和时间管理能力。
  • 出色的英语口头和书写能力。