Auditor

Job Title: Auditor

Job Location:

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

LOCATION Japan, Remote ENGAGEMENT TYPE Freelance, contractor, project based FUNCTION Quality, Audit, Life Sciences Consulting OVERVIEW ProPharma is seeking experienced freelance life sciences auditors based in Japan to support upcoming client audit activity on a project based contractor basis.

We are interested in speaking with senior quality, compliance, clinical research, pharmacovigilance, PMS, GVP, GPSP, and GMP professionals who have hands on audit experience in Japan.

This opportunity may suit candidates with experience in one or more of the following areas:

**GCP audits, including investigator site audits, CRO audits, vendor audits, sponsor process audits, or clinical quality systems

GVP, GPSP, PMS, pharmacovigilance, safety, case processing, call center, or post marketing related audits

GMP audits, including small molecule API, manufacturing, supplier, vendor, or quality system audits**

The work may include onsite, remote, or hybrid audit activity depending on the assignment, client requirements, and auditor availability.

This is not a permanent employee position. Assignments will be offered on a freelance contractor basis, typically linked to specific client audit needs.

KEY RESPONSIBILITIES

• Plan, conduct, and report audits in line with applicable regulations, client requirements, and internal procedures.

• Perform audits across relevant life sciences environments, including clinical research, pharmacovigilance, PMS, GVP, GPSP, GMP, vendors, suppliers, sites, CROs, and outsourced service providers.

• Review operational processes, documentation, quality systems, vendor oversight, and compliance controls.

• Identify audit findings, assess compliance risk, and prepare clear, well structured audit reports.

• Support follow up activities, including review of root cause analysis, CAPA responses, and closeout actions.

• Engage professionally with clients, auditees, and internal stakeholders.

• Support onsite audit activity within Japan where required.

• Deliver audit work independently while maintaining appropriate auditor objectivity and professional judgement.

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 an...