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QA Director (GCP Audit) 14M
- High salary around 14M depending on experience
- Upcoming approval in early 2016 and strong pipeline
About Our Client
Medium size European Pharmaceutical maker with strong R&D Pipeline and an upcoming product approval in early 2016. Located in Central Tokyo.
Evaluate whether clinical trial conduct and compliance with the GCP, the protocol, SOPs, and the applicable regulatory requirements independently of and separately from routine monitoring or quality control functions in order for a sponsor to implement a quality management of clinical trial. Furthermore recommend auditees to create CAPA Plan, if necessary. To enhance the GxP compliance in Japan and compliance with the company Quality Management System through collaboration with and reporting to Global Quality Assurance.
The Successful Applicant
Have documented experience as Lead Auditor from another company or have participated in audits lead by a certificate lead auditor
Documented experience with GCP audit, 3+ years
Skills and competencies in the relevant audit area must be maintained by performing multiple audits each year
Required Competencies (Behavioral Indicators)
- Business English level, in order to understand Protocol, Clinical Study Report (CSR), and make audits.
- Strong PC skills (MS word, Excel, PowerPoint)
- Ability to create documents
- Management skills
- Communication skills
What's on Offer