AI
Tokyo, Japan
ExcelLogistics
SS
Role overview
Job description
For nearly 30 years, SQA Services has been a leading provider of managed supplier quality services, offering audits, assessments, remote surveillance, corrective actions, remediation, inspections, and engineering solutions to manufacturers across all industries. We deliver these services by deploying a network of highly skilled associates based throughout the United States and in over 90 countries worldwide, ensuring rapid on-site support at your supplier locations. Our associates are expert quality assurance professionals with extensive experience and local expertise, enabling us to represent our clients on-demand and with greater speed and efficiency than our competitors.
We’re hiring a Pharma Quality Auditor. This is a contract opportunity in which you will perform supplier quality audits at various suppliers in Japan. These audits are generally 1-2 days long. You are given the flexibility to accept or reject these assignments according to your own availability.
Key Responsibilities
Perform supplier audits at various sites within your region of residence
Assure quality in the supply chains of various clients within the pharmaceutical, medical device, cosmetics, biologics, and/or animal health industries
Coordinate, prepare, execute, and deliver supplier audits based on your own and the client schedule
Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc…
Respond to the Content team in a timely manner regarding edits/questions to your audit report
Write audit reports in accordance with client specifications
Required Qualifications
5+ years of hands-on audit experience in pharmaceutical, medical device, and/or biologics industries
Has been the lead auditor in at least 10 audits
Direct audit experience to 21 CFR 210/211, EU Vol 4, ISO 22716, and ISO 9001
Strong communication and writing skills
Proven ability to deescalate workplace conflicts effectively
Ability to adapt to new technology and software.
Willingness to travel regionally
Preferred Qualifications
Direct audit experience to ISO 17025, ISO 15378, IPEC GDP, ICH Q7 and/or ISO 13485
ISO certifications are a plus but not mandatory
Note: SQA is an Equal Opportunity Employer. Employment is based on merit and qualifications, and is not influenced by race, color, religion, gender, national origin, veteran status, disability, age, sexual orientation, gender identity, marital status, or any other legally protected status.
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About this listing
- Source: SQA Services's official careers site · still listed there on 13 Nov 2026
- Posted 23 Oct 2026
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What they are looking for
Skills & requirements
Department · Life Sciences
Hiring company
SQA Services
Technology
SQA’s global network of quality experts represents the tip of the iceberg in terms of SQA’s capability, reliability, and accountability. Behind every carefully selected SQA Associate, there is a technical and administrative support team, a series of proven tools and processes, and a world-leading event management system providing unparalleled visibility and control.
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