Senior Quality Quality Specialist

東京都 外資系企業 外資系企業
  • Responsible for Conducting Oversight to Ensure Quality Compliance
  • Contribute to Approval of Innovative New Medicines


  • Industry leading US pharmaceutical company, with expertise in oncology, immunology, infectious disease, cardiovascular disease areas


  • Maintain and update the Clinical Trial Quality Management system to be current with industry standards, guidance, and best practices
  • Contributes to the development and review of SOPs and other controlled documents (forms, templates, work instructions)
  • Manages the incident management program through monitoring of complaints, deviations, and CAPAs
  • Independently schedules, plans, coordinates and conducts vendor/supplier audits, internal audits, compliance visits, for-cause audits and clinical trial site audits
  • Prepares required documentation to support audit activities including; audit plans, audit reports, audit certificates, and corrective action plans
  • Accountable for the accuracy of audit findings, a written audit report, and follow-up activities to assure that non-compliance issues are addressed with a satisfactory resolution
  • Review trial-related documents e.g. protocols, protocol amendments, ICFs, pharmacy manuals, and CSRs
  • Apply regulations, guidance document requirements, and study protocol requirements to clinical trial studies
  • Participate in solving GCP compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance
  • Support joint efforts in training on company procedures, GCP regulations, and documentation systems to assure compliance with company policies and regulatory standards
  • Maintain all associated QA department spreadsheets tracking of deviations, CAPAs, complaints, audit findings, and audit files as applicable
  • Assist in the development and implementation of inspection readiness at all times
  • Assists senior staff during regulatory inspections or other audits
  • Represents QA department at internal and external meetings supporting clinical programs
  • Strong communication skills (written and verbal), to serve as a resource regarding interpretation and application of quality requirements, concepts, and industry best practices


  • Over 5 years of work experience in the pharmaceutical industry
  • Work experience related to quality control or quality assurance related to new drug approval (GCP compliance survey) or reexamination compliance survey (GPSP compliance survey)
  • Problem-solving skills
  • Assertive communication
  • Knowledge of related regulations (ICH-GCP, J-GCP, GPSP, etc.)
  • TOEIC 700 points or more (English document preparation, meetings, email correspondence available)
  • Have the ability to properly identify the gap between the current state of the organization and what it should be, and deal with that gap


  • Work in an international environment, clear career development opportunities, contribute to global clinical studies
Ed Marsden
+813 6832 8981


Ed Marsden
+813 6832 8981