外資系製薬メーカー Associate Director, Clinical QA
- 職種Associate Director, Clinical QA
• Minimum BS degree in Chemistry or related life sciences discipline required with minimum 5－7 years of experience.
• Advanced degree （MS, PhD, MBA） preferred. In lieu of advanced degree, additional years of equivalent experience will be considered.
• Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required.
• An understanding of drug and device regulations, development processes and HA inspection procedures is required.
• English fluency is required.
• Experience developing SOPs, reviewing internal clinical, pharmacovigilance, regulatory and medical processes to ensure they are accurately represented in current SOPs is essential.
• Ability to organize and conduct internal audits is necessary.
• Ability to conduct external audits on Investigator Sites, CROs, supporting laboratories, and monitoring organizations with responsibility for writing audit reports as well as reviewing and tracking QEs/CAPAs.
• Broad knowledge of risk－based quality systems approaches consistent with ICH E－6 for Good Clinical Practice and Good Pharmacovigilance Practices.
• Requires solid experience with Phases I－IV （particularly Phase III）; experience with Regulatory approval, JNDAs is required, some experience with NDAs and MAAs would be preferred
Responsibilities will include, but are not limited to, the following:
• Full understanding of and practical experience establishing and fostering compliance with global ICH E－6 Good Clinical Practice and practical knowledge of Good Pharmacovigilance Practice and Good Laboratory Practice.
• Full understanding of and practical experience with Japan / Asia Pacific GCP regulations and practical knowledge of regional GVP.
• Establish and maintain GCP/GVP inspection readiness and act as the company’s representative during regulatory agency inspections and vendor audits in the region.
• Establish and maintain inspection readiness of clinical vendors, investigator sites and external contract organizations in the region.
• Responsible for quality assurance program in supporting GCP/GVP activities; this includes overseeing and assisting with training and auditing programs, development and review of SOPs/WIs （global/regional/local）, conducting vendor and site audits, as well as writing and reviewing QEs/CAPAs in the region.
• Foster a risk－based and scientific－based quality system to support GCP/GVP.
• Organize and conduct internal clinical system process audits, global and regional.
• Utilizes a quality system approach to ensure all GCP/GVP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence.
• Contribute to operational excellence initiatives, both in the department and companywide, which result in the overall improvement in both areas.
• Partner with colleagues in Clinical, Pharmacovigilance, Regulatory, and Medical departments to increase the overall effectiveness of the Quality role and instill a Quality Improvement approach in all activities.