GVP/GCP Auditor, Compliance & Quality Assurance – Japan

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.

ProPharma is looking for a GVP/GCP Auditor to join our Compliance & Quality Assurance team in Japan.

This is an opportunity for an experienced Clinical Quality or Pharmacovigilance Quality professional to take the next step in their auditing career within an international environment.

The role will support our global audit activities in Japan, with a particular focus on GCP/clinical and GVP/pharmacovigilance audits. We are especially interested in candidates who have experience across both areas, although strong experience in either Clinical/GCP or PV/GVP auditing may also be considered.

You will work closely with global colleagues and clients while developing into a trusted in-country auditing resource for Japan.

Importantly, we are not looking for someone who already knows everything on day one. You will be supported as you build further audit capability, broaden your experience and take on increasing responsibility within the team.

Your responsibilities may include:

• →Plan, prepare for and conduct GCP and GVP audits
• →Perform audits of clinical investigator sites, clinical trial activities, vendors, CROs and other GxP systems and processes
• →Support pharmacovigilance and safety-related audits
• →Evaluate compliance with applicable Japanese and international regulations, guidance and quality standards
• →Prepare clear, accurate and professionally written audit reports
• →Communicate audit observations and findings effectively with clients and auditees
• →Support corrective and preventive action activities where appropriate
• →Participate in internal quality activities and internal audits
• →Contribute to peer review and quality review of audit documentation
• →Participate in training and continued professional development
• →Work with subject matter experts and colleagues across ProPharma's global Quality and Compliance organization
• →Contribute to wider team initiatives, which may include knowledge sharing, thought leadership, articles, professional networking and other projects

The workload will naturally vary depending on client requirements. During quieter periods, you will have opportunities to strengthen your technical expertise, participate in internal projects and continue developing your auditing capabilities.

We would like to speak with candidates who have a strong foundation in clinical quality, pharmacovigilance quality, GCP, GVP or GxP auditing.

Ideally, you will bring:

• Professional experience within the pharmaceutical, biotechnology, CRO or related life-sciences industry
• Hands-on experience supporting or conducting GCP and/or GVP audits
• Experience with clinical or investigator-site audits would be particularly valuable
• Knowledge of Japanese regulatory requirements and the PMDA environment
• Working knowledge of relevant international requirements and guidance, including ICH GCP
• Experience with audit preparation, audit conduct, documentation and reporting
• Strong quality orientation and attention to detail
• Good analytical and problem-solving skills
• A scientific or related university degree

Recent hands-on audit experience is highly desirable.

This is a genuinely international position.

You will need:

• Fluent Japanese
• Strong professional English

You should be comfortable communicating with international colleagues and clients, participating in meetings in English and producing clear professional documentation.

Technical experience is important, but so is mindset.

We are looking for someone who is:

• Proactive and self-motivated
• Comfortable taking ownership of their work
• Curious and interested in continuing to develop professionally
• Able to work independently while collaborating effectively with a global team
• Confident communicating with clients and colleagues
• Willing to contribute outside the immediate scope of individual audit assignments
• Interested in building broader expertise across Clinical Quality and Pharmacovigilance Quality
• Comfortable working in an environment where priorities and workload can change according to client needs

You do not need to be the most senior auditor in the market.

We are particularly interested in professionals who already have a solid quality and auditing foundation but who still want the opportunity to develop, broaden their audit experience and grow into a highly capable international auditor.