1-617-500-6690 [email protected]
  • Full Time (Salaried)
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Company:  Confidential

Job Title: Director QA / GCP

Job Number: 30945

Location:

Job Description

The Director, GCP Quality Assurance (QA) will support the organization by providing quality management oversight for TS clinical trial activities. You will create and execute GCP quality management strategy for all ongoing TS trials and development projects. This includes developing and executing quality plans, conducting quality reviews, developing risk-based audit program and plans for GCP activities , coordinating and participating in GCP audits, as well as hosting audits form external parties, including inspectional activities as appropriate. This role will also support due diligence activities for licensing opportunities. An integral member of the project team, you will foster cross-functional partnerships, lead risk management activities (risk identification, evaluation, control/mitigation, reporting) and provide pragmatic and sensible interpretation of the applicable regulations. You will closely collaborate with other members of the QA team and coordinate activities to ensure GXP compliance of TS activities.

Responsibilities

  • Development and implementation of GCP quality management at TS
  • Lead the GCP QA Strategy implementation
  • Represent GCP QA at project team meetings
  • Conduct and oversee GCP audits and inspection activities as needed 
  • Evaluate status of GCP compliance for management reporting 
  • Provide sensible interpretation of GCP regulations

Required Skills

  • B.S. in a scientific or a health care-related field.
  • Minimum of 10 years of increasing responsibility in clinical development, clinical trial quality or GCP QA.
  • In-depth knowledge of the application of GCP regulations, ICH Guidelines, FDA Regulations and Guidance
  • Experience in implementing quality management programs for clinical development activities
  • Experience in conduct and oversight of clinical investigator site, vendor and process audits 
  • Experience in hosting regulatory inspections
  • Must be able to effectively communicate potential quality and compliance risks in order to enable appropriate corrective actions
  • Must possess the ability to effectively manage multiple projects
  • Management experience is a plus

 

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