GCP Quality Compliance Lead at Global Healthcare Tech

Reporting APAC in a stand alone position. Be a key member in clinical quality management to ensure effective compliance.
Client Details
* 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
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.