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Associate Director Clinical Quality Assurance

Cambridge, Massachusetts 02142

Post Date: 04/18/2018 Job ID: 1920 Job Category: Clinical: Quality

The Associate Director Clinical Quality Assurance will conduct audits of external providers including CROs, vendors and clinical trial sites along with internal documentation, system and process audits. The Associate Director is also responsible for the initiation, conduct, and follow-up of audits as assigned. This position reports to the Sr. Director Clinical Quality Assurance.

Job Responsibilities:
  • Development of Master Audit Plan for Clinical and Nonclinical (GLP)
  • Ensure that the audit plan is implemented, in order to provide assurances that clinical and nonclinical studies are of the highest quality standard and are in compliance with the requirements of company SOPs, study protocols, relevant regulations (GXPs) and ICH guidelines / GCP and GLP regulations
  • Ensure that audit results are formally and consistently recorded, reported, monitor trending and also ensure that corrective/preventive actions have been requested and documented effectively
  • Managing vendors and CROs during external and internal auditing
  • Development, training and maintenance of Clinical SOPs and Training Plan
  • Document QC (Trial Master Files, CSRs, Protocols, submission documents etc.
  • ICH/GCP Training at investigator meetings and internally
  • Assist in BIMO and Inspection Readiness Activities
  • Manage Audit Consultants and Internal Auditors


Requirements:
  • Qualified candidate must possess a bachelor' s degree in Science, or equivalent degree/experience
  • Demonstrated experience with SOP and or GCP Training
  • Demonstrated experience conducting GCP audits and/or hosting regulatory authority inspections
  • Strong GCP knowledge and experience with 5-8 years of direct GCP experience working in a pharmaceutical or biotechnology firm and or with a CRO is required
  • Previous GMP or GLP experience preferred but not required
  • In depth knowledge and understanding of drug development and the clinical trial process
  • In depth knowledge of current regulatory requirements and experience with global regulations and guidelines
  • Experience in developing and implementing Quality Management Systems
  • Team building and leadership skills
  • Strong written and oral communication skills
  • Computer/technical skills
  • Other position-related skills (i.e. project management skills, team collaboration, detail-orientation, management skills, other soft skills, etc.)

Demeika Roberts

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