医薬開発本部クオリティメディシン部 コンプライアンスマネージャー BI20180626-4
＜Basic Purpose of the job ＞
The Compliance Manager role is an integral part of the quality management system in BI Clinical Development, Medicine. The Compliance Manager plays a critical role in supporting Medicine for GxP compliance issues and driving the organization on pro-active quality management. He/she provides GxP guidance and consultation. The position provides assessments of Medicine activities 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.
1. Compliance expert
Provide GxP/Regulatory/SOP/WI guidance, consultation, coaching, mentoring, including sharing of best practices within the OPU/regional Medicine organization. Liaises with international CPM colleagues regarding compliance topics.
・Feedback from fellow compliance managers, line managers and customers.
2. 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.
・Improvement projects supported and QIPs available and timely followed up.
3. CRO Quality Management
Assess and ensure implementation of relevant BI SOPs & WIs at CROs conducting BI 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 work with business partners in incorporating quality elements into Scopes of Work.
・Risk assessment report available and mitigating actions implemented. Visits conducted as required, including availability of visit reports. SOPs/WIs exchange with CROs established.
4. 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 BI compliance position in regulatory authority inspections, as appropriate.
Ensure inspection findings are appropriately addressed, response provided and adequately followed up.・Successfully coordinated regulatory inspections. Responses provided, accepted and followed up in timely manner.
5. 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.
Analyze non-compliance trends and provide periodic updates to management of the OPU/region.
・Adherence to timelines and requirements. Continuous monitoring of KPIs. Availability of audit action plans, NC Alert and CAPA forms.
6. Participate in global compliance projects, as applicable.
・Implementation and completion of global compliance projects.
＜Other regulatory and / or Organizational Requirements＞
Current knowledge in applicable company processes and procedures with ability to assess impact of these processes/ procedures across Medicine.
Quality Medicine colleagues from all disciplines and various managerial levels, Medical Director, most functions in Clinical Operation, Translational Medicine, Pharmacovigilance, Drug Regulatory Affairs, Medical Affairs, Quality Assurance of other business areas, CTSU.
Degree / Education ： Bachelors Degree 学部卒
Major / Focus ： Biochemistry 生化学、生物（生理）化学
Medicine, pharmaceutics or others
Proficient/expert knowledge in ICH GCP, Pharmacovigilance and/or Regulatory Affairs and applicable regulations/guidelines (2+ years’ experience in clinical trial management and/or in-depth knowledge of clinical development process).
- Experience with/participation in Regulatory Authority Inspections
- Excellent communication, collaboration, and decision making skills
- Ability to act independently and effectively prioritize.
- Ability to communicate/liaise with all levels of the organization
- Good team working capabilities
- Ability to travel regionally and internationally as needed.
＜Language Skills & Proficiency＞
＜Yeas of leadership experience＞
Int'l exposure in daily business (>50%of international business / customers / staff)
：> 1.5 years
＜Special Work Experience＞
2+ years’ experience in GxP environment and in-depth knowledge of clinical development processes.
- Proficient/ expert knowledge in ICH GCP and applicable regulations/guidelines.
- Experience with/participation in Regulatory Authority Inspections preferred.
Current knowledge in applicable Company processes and procedures.
Ability to assess impact of these processes/procedures across Medicine.