Quality & Regulatory Affairs Specialist (Biotech/Pharma SaaS/Cloud Solutions)

My client, a leading North America based provider of software as a service (SaaS) and cloud computing solutions to the pharmaceutical, biotech and life sciences industries, is seeking a Quality & Regulatory Affairs Specialist to perform operational and business related tasks for the Quality & Regulatory Affairs (QRA) department.

The Quality & Regulatory Affairs Specialist will be based in Tokyo where he or she will work with company management and staff along with auditors and other representatives from the company’s customers and partners to:

  • Schedule, prepare for, host, support and follow up with customer and partner audits.
  • Provide support for various QRA programs e.g. Corrective and Preventive Action (CAPA) programs, internal/external quality system programs, supplier evaluations / audit programs.
  • Handle or support various ad hoc quality and regulatory or documentation requests from internal departments or from customers and/or partners.


  • At least three years of experience conducting audits.
  • Knowledge about relevant quality management systems.
  • An understanding of the regulatory requirements for the pharmaceutical, biotech and life sciences industries plus clinical studies.
  • Experience with Corrective Action Preventive Action (CAPA) Programs.
  • English/Japanese fluency.


Base salary + benefits + bonus potential


Please send a CV (plus any current compensation information) to John AT braingainasia.com or message/connect with me on LinkedIn at http://www.linkedin.com/in/johnudovich.

About Brain Gain Asia LLC

Brain Gain Asia LLC (http://www.braingainasia.com; http://twitter.com/BrainGainAsia) is an international executive search firm focused on recruiting local, returnee and expatriate candidates for jobs in Asia. Specifically, our firm is specialized in identifying and recruiting Asian expatriates and returnees who have either lived, studied and/or worked abroad in Western countries such as Australia, Europe and the USA and who intend to remain in or return to the Asia region or to their home countries for career and job opportunities.

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