主要工作内容：13 负责临床试验的质量管理，确保项目按照GCP和相关法规以及公司SOP的要求进行 负责国家局核查及前期准备工作，评估临床试验风险并提出改进建议，跟踪发现的审计问题直至关闭 持续关注法律法规、行业规范的更新变化，持续进行质量改善 Basic purpose of the job The Compliance Manager role is an integral part of the quality management system in our FSP Client Medicine. The compliance manager plays a critical role in supporting Medicine for GxP Compliance issues and driving the organization on the pro- active quality management. He/She provides GxP guidance and consultation. The position provides assessments of activities in Medicine with company procedures, GxP, ICH guidelines and other regulations; identifies and assesses areas of risk; proposes corrective and preventative actions; assists with development and implementation of process improvements. Accountabilities Compliance expert: - Provide GxP/Regulatory/SOP/WI/KMed Asset guidance, consultation, coaching, mentoring, including sharing of best practices within the OPU/regional Medicine organization as required. - Liaises with international CPM colleagues regarding compliance topics. Quality Improvement: - Identify and support improvement actions within the OPU/regional Medicine organization, aligned with global quality improvement projects and compliance strategy - Identify areas for improvement and support the initiation of quality improvement projects. - Identify areas of improvement for quality management in the OPU/region responsible. - Support Global quality improvement projects where appropriate. CRO Quality Management: - Assess and ensure implementation of relevant BI SOPs & WIs at CROs conducting FSP client trials. - Ensure pre-qualification visits at new CROs are performed, in collaboration with other functions, as applicable. - Ensure oversight of Quality related risk in relation to vendor management and development of mitigating actions in collaboration with other functions, as applicable. - Support business partners in the investigations and development of CAPA plans related to CRO non- Compliances. - Pro-actively works with business partners in incorporating quality elements into scopes of Work. Regulatory Inspection support: - Lead inspections and drive inspection processes as needed ( e.g. Primary contact person, inspection lead) - Support and provide guidance relating to optimized inspection readiness and inspection preparation activities. - Lead and represent FSP client compliance position in regulatory authority inspections, as appropriate. - Ensure inspection findings are appropriately addressed; response provided and adequately followed up. Corrective and Preventive action process: - Provide support to auditee, as appropriate, including review of audit action plans as proposed by business function. - Support/ facilitate the handling of major and critical non-compliances as detailed in corporate SOP. - Ensure KPI timelines adhered to, tracked and followed up as applicable. - Analyse non-compliance trends and provide periodic updates to management of the OPU/ region. Participate in global compliance projects, as applicable. Regulatory and/or Organisational Requirements Current knowledge in applicable company processes and procedures with ability to assessimpact of these processes/ procedures across Medicine. Job Complexity Acts in the context of GxP within external and all FSP Client's internal regulations. Interacts with mid-senior management of FSP client. Implementation of new or optimised processes which effects to the whole Medicine organization. Avoidance of findings in inspections. Highlight innovative solution concepts, distinctive negotiation skills and expert for change management. Interfaces Global, regional and local leaders within Medicine Heads of QM, QM Colleagues Sourcing, Legal, IT Medicine business functions, CHC Vendor staff Regulatory Authorities Quality departments in Development and Operations Job Expertise Proficient in business critical compliance and quality management and enabling compliance standards and oversight. Considerable experience of GCP/Pharmacovigilance quality management systems. Good understanding of Medicine processes in product development and post approval. Job Impact High. QMS is essential to ensure quality and compliance of the Medicine organisation in the country. This forms the basis to operate in compliance. Loss of compliance can lead to withdrawal of marketing authorizations, significant fines, imposed oversight from regulators, reputational damage or overall access to sell products in individual markets as well as impact on important regulatory agencies such as PMDA, EMA and FDA globally. Minimum Education/Degree Requirements Degree/ Education: Bachelors and/or Master Degree and/or Doctoral Degree Major/ Focus: Medicine and/or Pharmaceutics and/or others Required Capabilities (Skills, Experience, Competencies) Skills: 61 Proficient/expert knowledge in ICH GCP, Pharmacovigilance and/or Regulatory Affairs and applicable regulations/guidelines (6+ years’ experience in clinical trial management and/or indepth knowledge of clinical development process). 61 Experience with/participation in Regulatory Authority Inspections 61 Excellent communication, collaboration, and decision making skills 61 Ability to act independently and effectively prioritize. 61 Ability to communicate/liaise with all levels of the organization 61 Good team working capabilities 61 Ability to travel regionally and internationally as needed. Language Skills & Proficiency: English (Read: fluent;Write: fluent;Speak: fluent); Chinese (Read: fluent;Write: fluent;Speak: fluent) Experience: 1-3 years of leadership experience; International exposure in daily business (＞50% of international business/customers/staff) ＞ 1.5 years Special Working Experience: 6+ years experience in GxP environment and in-depth knowledge of clinical development processes. - Proficient/ expert knowledge in ICH GxP and applicable regulations/guidelines. - Experience with/participation in Regulatory Authority Inspections preferred. - Experience in Quality Management. - Current knowledge in applicable Company processes and procedures. - Ability to assess impact of these processes/ procedures across Medicine. Competencies: AAI (Accountability, Agility, Intrapreneurship
