臨床開発 [ID: 0015]

外資系製薬メーカー Associate Director, Clinical QA

  • 会社区別外資系製薬メーカー
  • 職種Associate Director, Clinical QA
  • 勤務地東京
  • 年収~1500万円

資格・要件

• 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

職務内容

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.

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