GCP Quality Assurance Sr. Specialist at Global Biopharma

Tokyo 23 Wards Permanent ¥12,000,000 - ¥13,000,000 Foreign Multinational
  • Be part of one of the top stable global biopharma companies in the industry
  • Take lead in executing in global QA audit activities for GCP oversight

About Our Client

  • One of the top global biopharma companies in the industry
  • Rich pipeline from vaccines, oncology, immunology including track record of blockbuster products
  • Innovative and progressive therapies to meet unmet medical needs
  • Prides in supporting clients and patients focusing on various current events including the recent COVID-19 Pandemic

Job Description

  • Prepare QA audits, generating reports, results in relation to QA management to the clinical trial team as well as other cross function departments
  • Ensure corrective and prevention to include GCP related audits for investigator sites, laboratories, regulatory documents, and market applications
  • Develop of QA procedures, guidance documents, and audit tools to standardisation of auditing approaches
  • Provide inspection management support on GCP issues and knowledge of proper SOPs, regulations for global and local rules
  • Provides training and mentorship for junior members in QA staff

The Successful Applicant

  • In depth knowledge of GLP, GCP, GVP guidelines
  • Strong quality mindset including focus on details with standards
  • BS or BA degree in related scientific area with experience in the pharmaceutical industry including conducting broad range of audits
  • Knowledge with company systems, policies, and procedures for multiple therapeutic areas and nonclinical studies
  • High fluency in English and Japanese (non Japanese speakers will not be selected)

What's on Offer

  • Competitive salary and benefits
  • International working environment
  • Great work life balance
  • Amazing career progression in QA
  • Work with key industry people who are solving unmet medical needs
Zach Itozu
Quote job ref
Phone number
+813 6832 8683

Job summary

Healthcare / Pharmaceutical
Tokyo 23 Wards
Job Type
Consultant name
Zach Itozu
Consultant phone
+813 6832 8683
Job Reference
Company Type
Foreign Multinational