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Director Clinical QA

Reference Number: 3260
Location: MA

Our client is a leading biotechnology company.  They have asked us to assist them in their search for a Director, Clinical Quality Assurance.

Major tasks and responsibilities will include:

  • Provides strategic direction to the development and execution of audit activities for assigned programs.
  • Collaboratively works with key stakeholders to ensure a robust audit strategy.
  • Ensures the appropriate corrective and preventive actions are completed in a timely manner.
  • Identifies potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation.
  • Escalates issues of critical noncompliance and/or lack of urgency in remediation to senior management, as appropriate.
  • Develops an overarching strategy related to proactive and sustainable compliance for the assigned programs.
  • Serves in an advisory/consultative role in compliance related issues and supports Program teams in implementing corrective and preventive actions.
  • Promotes a culture of inspection readiness and sustainable compliance.
  • Works with other R&D QA & Compliance functions to perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking, trending for the overall reporting requirements to functional and senior management.
  • Participates in Due Diligence activities as appropriate.
  • Develops and manages the strategies for the preparation, hosting and responses to regulatory agency inspections for GCP/Sponsor Monitor inspections and investigator site audit inspections for assigned programs.

We seek candidates with the following qualifications:

  • Must have a Bachelor’s degree in a life science related subject.
  • Master’s degree in management or scientific discipline preferred.
  • Must have at least 10 years of experience in the pharmaceutical industry.
  • Must have a broad experience in product development, clinical operations, regulatory compliance, GCP auditing and at least 7 years of direct management experience.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3260. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.