14794 Clinical QA/GCP Associate Director
・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.
・Minimum BS degree in Chemistry or related life sciences discipline required with minimum 5 years of experience.
・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 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.