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Manager/Senior Manager Clinical Quality Assurance

Job summary

  • Conduct and manage global GCP audits including investigator sites, vendors and internal processes.  Manage audit report responses and track completion of responses. Provide GCP expertise in support of clinical study teams.  Participate in Regulatory Agency inspection and inspection preparation activities.

Essential job functions and duties

  • Conducts and manages GCP audits including investigator sites, vendors and internal systems/processes
  • Ensures adequate audit report responses and tracks actions to completion
  • Acts as CQA liaison to study teams
  • Provides guidance and shares expertise in the interpretation of GCP regulations and guidance
  • Ensures timely completion of the audit schedule
  • Supports Regulatory Agency inspections and inspection readiness activities
  • Contributes to CQA problem solving. Identifies potential compliance issues and proposes solutions
  • Other duties as assigned

Minimum requirements

  • Bachelor’s degree required in a relevant discipline
  • Minimum five years’ experience in performance of GCP audits and management of audit responses
  • Knowledge of US and international Pharmaceutical regulations, guidelines, and directives from agencies such as FDA, EMA, MHRA along with experience with ICH GCP guidelines
  • Ability to travel globally a minimum of 30%
  • Advanced computer skills, particularly with MS Word, Excel and the internet
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