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Updated 2024-04-05
Activated 2024-04-05
Activated 2024-04-05
GCP Quality Compliance Lead at Global Healthcare Tech
- Recruiter
- Manager Level
| This posting is managed by: | Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社 |
|---|---|
| Company Name | Company is not publicly visible |
| Job Type |
 Medical/Pharmaceutical/Bio/Fabric/Food - Clinical R & D |
| Industry | Medical/Healthcare Services |
| Location |
Asia
Japan
Tokyo
|
| Job Description |
Reporting APAC in a stand alone position. Be a key member in clinical quality management to ensure effective compliance. Description * Supporting clinical quality management including ICH GCP, clinical regulations/requirements, data management of clinical trials * CSV * Supporting clinical trial processes including eTMF, TMF, SMF * Operate in quality incident management, internal quality system audits, customer audit/inspection Profile * University degree in scientific or related field * High fluency in English and Japanese (non-native level speakers will not be selected) * Clinical quality experience with strong understanding of ICH GCP ideally in the pharmaceutical industry * CSV experience * Exposure to quality systems processes including auditing, root cause analysis, and CAPA development * PMDA inspection experience is preferred * Ability to work independently Job Offer * Competitive salaries and benefits * Great work life balance * International working environment * Hybrid working environment * Work with industry leaders who are solving unmet needs * Great career progression Page Group Japan is acting as an Employment Agency in relation to this vacancy. |
| Company Info |
* Global healthcare technology company specialising in digitisation for clinical trials * Supporting over 30,000 clinical trials around globe * International working environment with extensive global collaboration * Hybrid working style |
| English Level | Business Conversation Level (TOEIC 735-860) |
| Japanese Level | Native Level |
| Salary | JPY - Japanese Yen JPY 12000K - JPY 14000K |
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Recruiter
Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
