Director, Quality Assurance

Posted 52ds ago

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Job Description

Director of Quality Assurance managing QA strategies and ensuring compliance for clinical trials. Leading a team to uphold quality standards and fostering stakeholder collaboration in healthcare.

Responsibilities:

  • Formulation and execution of a viable, results-oriented strategy for assigned area.
  • Establish, promote and sustain a vision, mission, strategic and policies for quality assurance; communicate them to team, along with internal and external clients in a spirit of shared partnership.
  • Oversee the coordination and hosting of cross-functional Sponsor Audits and Regulatory Inspections, as well provide management support to QA staff for Sponsor Audits and Regulatory Inspections.
  • Implement yearly risk-based audit plan for the area of responsibility, and continuously evaluate risk and adjust audit plan accordingly, coordinate with peers and ensure execution of the annual audit plan.
  • Champion and support compliance with applicable regulations, laws, Parexel procedures and policies.
  • Promote a vision and action for compliance and standards across the company, fostering cooperation, globalization and positive communication.
  • Actively implement and support the use of Audit Management application and related metrics.
  • Support the recruitment, supervision, training and mentoring of the QA team.

Requirements:

  • 15+ years’ experience in quality assurance or relevant area, including 5 years of applicable GxP auditing.
  • 7+ years managing a team.
  • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience.
  • Strong command of written and spoken English language, local language proficiency as required.

Benefits:

  • Travel internationally on assignments as required.
  • Travel time could be up to approx. 60%.