GVP/GCP Auditor, Compliance & Quality Assurance – Japan

Job description

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. About the role 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. What you will do 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. What we are looking for 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. Japanese and English 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. The kind of person who will succeed here 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. Why join ProPharma? This role offers more than simply moving from one audit to the next. You will have the opportunity to: Work on a variety of Clinical/GCP and PV/GVP audit activities Develop experience within a global Quality and Compliance organization Work with experienced auditors and subject matter experts internationally Continue developing through training, peer review and practical experience Build exposure to different clients, audit types and quality systems Take increasing ownership of audit activities in Japan Contribute ideas and expertise to the wider business For someone who enjoys auditing but also wants the opportunity to learn, develop and help shape how a growing audit capability operates in Japan, this could be an excellent next step. 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.***