À propos de ce poste Auditor chez ProPharma
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 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.***
