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Clinical Quality Senior Manager - Cambridge, Massachusetts

Posted 21 March by Haybury Limited Easy Apply Ended

This will be a highly visible position within a unique market leading pharmaceutical group. As the Clinical Compliance subject matter expert, you will be responsible for evaluating and improving processes to ensure compliance, quality and process efficiency of clinical trials.

With strong influencing skills, you will have the authority to lead and implement Clinical Compliance principles across the global group.

Responsibilities may include:

  • Support Global Quality, Compliance and Improvement initiatives
  • Define and implement strategy to support Clinical Development projects
  • Clinical Compliance submissions to regulatory agencies
  • Identify and mitigate Quality and Compliance risks
  • Define and deliver training for CAPA, Non-Conformance and Root Cause Analysis
  • Support Inspection Readiness

Required expertise/experience:

  • Degree in Life Sciences
  • Extensive experience of Clinical Quality Assurance
  • Strong project management skills
  • High level CAPA expertise
  • Interaction with Regulatory authorities/inspections
  • GCP and/or GVP QA auditing experience a plus

In return you will receive

  • High level SME position in a dynamic and unique global environment
  • Contribute to the strategic direction of Clinical Quality Assurance
  • Highly competitive salary
  • Located close to future site of EMA

If you have the experience, expertise and ambition for this opportunity, please contact Scott today

Scott is QA Senior Client Partner at Haybury Search covering North America, Europe, UK, and Asia.

Keywords: compliance, CAPA, "corrective and preventive action", "root cause analysis", Non-conformance, clinical, QA, QMS, "quality management systems", "quality assurance", "regulatory authorities", inspections, strategy, GCP, "clinical QA", CQA, "clinical safety", "drug safety", QA, quality, auditing, auditor, audit, deviations, GxP, GVP, "project management",

Reference: 34739608

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