Quality Assurance Lead

岗位名称: Quality Assurance Lead

汇报岗位: Executive Director, GCP Quality Assurance

部门:QA, RA, and GA

工作地点:Beijing

岗位概述
Manage and contribute the GCP and GLP and GVP Quality Assurance activities:
Develop/improve and contribute quality systems and processes.

工作职责

  • Conducting routine and for cause audit of investigator site, vendors, internal audits, etc.
  • Manage and review of quality issues
  • Creation/revision of appropriate SOPs
  • Supporting the activities related to the vendor management process training, SOPs, etc.
  • Conducting routine and for cause audit of investigator site, vendors, internal audits, etc.
  • Management and review of trends and report significant investigation/deviation issues and system deficiencies to senior management, as appropriate
  • Coordinate and/or administer GCP training, as needed
  • Participate and represent Clinical Quality in meetings and discussions as needed
  • Participate in the review of study related metrics (i.e; protocol deviation, etc.) as part of Quality
  • Management Risk approach to identify gaps, trends and the need for process improvements.
  • Manage the inspection readiness activities and lead regulatory health authority inspections.
  • Other duties as assigned

相关工作经验要求

  • Have 5 years GCP audit experience, quality control and clinical research associate experiences.
  • MNC working experience is preferred.

必要的学历和专业资格,含语言能力

  • Bachelor’s degree in biological sciences, medicine or pharmacology (or an equivalent mix of education and experience)
  • Excellent computer skills, including Excel, Word, etc.
  • Thorough knowledge of applicable GCP and GXP regulations, guidelines, policies, and procedures will be preferred.
  • Excellent verbal and written communication skills both in English and Chinese will be preferred.

必要的技能和能力

  • Thoroughly knowledge of GCP. Familiar with GVP or GLP is preferred