Freelance Life Sciences Auditor, Japan

REQUIRED EXPERIENCE

• Proven experience conducting audits within pharmaceutical, biotechnology, CRO, vendor, supplier, clinical research, pharmacovigilance, PMS, GVP, GPSP, GMP, or related life sciences environments.
• Strong working knowledge of applicable Japanese regulations and quality expectations in at least one relevant audit area.
• Experience preparing audit reports and managing findings through follow up and CAPA review.
• Ability to work independently on project based audit assignments.
• Native level Japanese language capability.
• Business level English, especially for written communication, audit documentation, client communication, or report preparation.
• Based in Japan and able to support onsite audit work when required.

SPECIALIST EXPERIENCE OF INTEREST

• We are particularly interested in auditors with experience in one or more of the following areas:
• ICH GCP and Japanese GCP
• Investigator site audits
• CRO, vendor, or outsourced clinical service audits
• Sponsor process audits
• Inspection readiness or mock inspections
• Japanese GVP and GPSP
• PMS monitoring support
• PMS data management
• Pharmacovigilance quality systems
• Case processing operations
• Call center operations related to medical information, safety, or pharmacovigilance
• Vendor audits for pharmacovigilance, PMS, or safety operations
• GMP audits for small molecule API sites
• Manufacturing quality systems
• Supplier or vendor qualification audits
• API, drug substance, or related manufacturing audit experience

PREFERRED EXPERIENCE

• Experience working as an independent consultant, contractor, or freelance auditor.
• Experience supporting international clients or global quality teams.
• Experience conducting audits in both Japanese and English environments.
• Experience with onsite audit delivery in Japan.
• Experience reviewing audit logs, audit plans, CAPA responses, and inspection readiness documentation.
• Ability to support short term or intermittent audit assignments throughout the year.

PERSONAL PROFILE

• Clear and credible communicator.
• Professional in front of clients and auditees.
• Comfortable working independently.
• Able to assess compliance risk and materiality of findings with sound judgement.
• Able to manage timelines, deliverables, and documentation accurately.
• Practical, flexible, and commercially aware when supporting project based client work.

ENGAGEMENT DETAILS

This is a freelance contractor opportunity. Specific assignments will depend on client requirements, audit scope, location, timing, and auditor availability.

Candidates do not need to have experience across all audit types listed above. Experience in one strong specialist area, such as GCP, GVP/GPSP, PMS, pharmacovigilance, or GMP, may be sufficient depending on the project.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***