Manager, GMP GDP Auditor (GMP/GDP)

Location: Japan - Aichi; remote, field-based position

Company

hirify.global develops and manufactures pharmaceutical and biopharmaceutical products under regulated quality and compliance requirements.

What you will do

• Independently plan and lead complex GMP/GDP audits of material suppliers, service providers, hirify.global facilities, and country offices.
• Participate in audits of commercial and clinical manufacturing sites and contract manufacturers.
• Prepare, execute, report, and follow up on audits using AI tools with human oversight, professional judgment, and source verification.
• Support quality programs, cross-GxP audit plans, vendor assessments, and outsourced audit reviews.
• Assess compliance risks, synthesize stakeholder feedback, identify trends, and develop recommendations.
• Suggest and operationalize new audit techniques, technologies, and digital workflows.

Requirements

• Bachelor’s degree or equivalent, preferably in pharmaceutical or natural sciences.
• Advanced knowledge of global regulations and standards, including FDA, ICH, PIC/S, EMA, Health Canada, ANVISA, TGA, ISO, and WHO requirements.
• Working knowledge of GMP/GDP regulations, quality operations, auditing frameworks, and standard operating procedures.
• Critical thinking, risk assessment, technical writing, organizational, project management, and data interpretation skills.
• Experience or specialization in at least one conventional technology area, such as APIs or solid oral dosages.
• Ability to communicate in both Japanese and English to a high standard.

Nice to have

• 5–7 years of operational or auditing experience.
• Experience with vendor audits and technology areas such as MDCP, sterile biologics, small molecules, or GDP.
• Data analytics experience and the ability to work autonomously in a matrix environment.

Culture & Benefits

• Field-based work involving physical and electronic observation of quality and compliance risks.
• Travel of up to 40% of the time, including domestic and international travel.
• Collaboration with RQA colleagues and multiple stakeholders across global operations.
• Opportunities to adopt new audit technologies and improve digital audit methodologies.