・Applicants must have permission to work in Japan
・Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)
☑外資系企業 ☑英語力が必要 ☑リモートワーク可能 ☑フレックス勤務
Team lead of "Development Quality Compliance and QMS"
1. (Global) GCP auditor role
Evaluate whether clinical trial conduct and compliance with the GCP, the protocol, SOPs, and the applicable regulatory requirements, independently of and separately from routine monitoring or quality control functions, for a sponsor to implement a quality management of clinical trial independently.
Furthermore, recommend auditees to create CAPA Plan and to follow up the course of CAPA implementations to complete the CAPA actions, if necessary.
Endure independent GMP compliant review and support release of Clinical Trials Supply materials(IMPs etc.) and documentation supporting clinical trial in Japan.
To enhance the GxP compliance in Japan R&D team and compliance with Quality Management System through collaboration with Global Quality Assurance.
Potentially to get involved in global clinical trial activities to support to global clinical quality team and collaborate with regional clinical quality team in various of GCP activities.
As a specific tasks of the position to take responsible below,
Establish and maintain systematic and continuous conduct of GCP and IMP GMP audit programme
Establish a written audit plan such as an annual plan and a plan specific to each trial or audit, based on the results of the risk assessment according to the written auditing procedures
・ Provide input to and align with the Global Audit Plan.
Conduct an audit as lead auditor in accordance with a written audit plan and procedures and involves the examination and evaluation of information obtained through investigation of the audit trial e.g. essential documents and SOPs and trial sites.
Provide written audit results, i.e. audit report for the sponsor to make to auditee recognize audit findings and take the opportunity to make improvements.
・ Provide audit result and CAPA plan input to the global Audit Management System (TrackWise/QA-Track).
・ Evaluate CAPA plan provided by the auditee
・ Check implementation of CAPA and its effectiveness
・ Engage a contract QA auditor in case of outsorcing QA activites
・ Provide sufficient support the global auditor to conduct the global audit.
・ Further collaborate the GCP activities with global/reginal GCQ team upon request.
・ The other relevant tasks in GCP activites (if applicable)
2. Quality Management System Manager
In addition of the above GCP auditor role, as collaborate responsible roles, rolling out, maintaining and facilitating the following GxP quality management system/tools and the relevant tasks to cooperate with Post marketing QA & M&S team and R&D team as a QMS manager for the entire local organization as well as to train local staff in QMS gradually making them execute QMS relevant tasks independently.
・ Document Management System (QualityDocs/Veeva) as for a local document & record management
Learning Management System as for ensuring training on Global and local SOPs in collaboration with global clinical team and reginal/local LMS leaders in relevant departments.
・ The other relevant system (TrackWise modules such as Audit)
・ The relevant local organizers in QMS activities of Quality Review Board(QRB), Global Quality Assurance Audit etc.
Continues GxP regulatory surveillance as for ensuring evaluation of impact from a new and/or updated regulation (local and international) and implementing the new regulation into local procedures, Global Policies and standards in coordination with Global QA and local team.
・ Monthly reporting in GCP activities for Global and regional organization
Ensure effective quality controls of new products as for ensuring integration all experiences of provision of IMPs into the product quality in collaboration with post marketing QA
・ The other relevant tasks in related to QMS (if required)
Hard skills and experiences:
- Over 3 years' experience in GCP
- Audit Working experience in global, multi-national environment
- Japanese: Fluent
- English: Business level (Report and Collaboration with global members, attending a global conference, etc.)
(Note) With regard to QMS skills and experiences, it is not necessary for the candidate to acquire the skills and experiences for applying for this position. We believe the candidate should be a highly motivated person to learn a new filed of the QMS skills and experiences.
Soft skills and experiences
- Multi-tasking with speed and accuracy
- Proactiveness and autonomous
- Inter-personal skill
Seniority Level: Mid-Senior level
Job Function: Quality Assurance