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Posted 1mo ago

Pharmaceutical Quality GMP Auditors (Consulting)

@ Advarra
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Tokyo, Tokyo, Japan
RemoteContract
Responsibilities:conduct audits, evaluate sites, prepare reports
Requirements Summary:10+ years clinical QA and GMP, 5+ years GMP auditing, FDA/EMA familiarity, QA program development, English and Japanese at B2 level, Bachelor's degree.
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Job Description

 If you’re not already part of our Network, please register using the Expert Enrollment Form.  https://advarra.my.site.com/experts/s/  Registration is required to be considered.

If you are in our network DO NOT fill out this form or click on the link.

Location

This role is open to candidates based in Japan. 

Company Information

At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each person is not only valued but empowered to thrive and make a meaningful impact.

Company Culture

Our people--both employees and consultants—are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.

Job Overview Summary

Advarra is seeking Good Manufacturing Practice (GMP) Auditors to join our consultant network for Japan-based projects. Auditors support compliance reviews across GCP clinical sites and vendors.

Job Duties & Responsibilities

  • Conduct Good Manufacturing Practice (GMP) audits (planning, agenda,  physical or remote audit, and report writing)
  • Evaluate investigator sites, CROs, and vendor compliance or qualification.
  • Prepare comprehensive audit reports detailing findings and root-causes.
  • Provide written audit reports in English.
  • If required will provide corrective actions support and present findings to QA leadership and stakeholders
  • Work collaboratively with clients to ensure quality standards.

Basic Qualifications

  • Minimum 10+ years of Clinical Quality Assurance and/or Good Manufacturing Practice (GMP) experience.
  • Minimum 5+ years of Good Manufacturing Practice (GMP) auditing experience.
  • Demonstrated experience with regulatory agency expectations (e.g., FDA, EMA) and audit readiness activities.
  • Demonstrated experience in developing and implementing quality assurance plans, audit programs, and corrective action plans.
  • B2 level in English communication, verbal and written 
  • B2 level in Japanese communication, verbal and written
  • Bachelor's degree 

Preferred Qualifications 

  • Strong interpersonal and client interaction skills.
  • Excellent analytical, problem-solving, communication, and report-writing skills.
  • Ability to work collaboratively across departments and interact with internal and external stakeholders.