Director, QA/Regulatory CDCS APAC
Laboratory Corporation of America Holdings (Covance)
Shanghai, China
3天前

This leadership role is highly visible within the global Covance Clinical Research organization and is central to delivering Covance’s value proposition to potential clients.

This positon is required to partner with executive Covance leaders to support the growth strategy and to drive a culture of quality, compliance, and continuous improvement in the organization.

  • This position oversees the Asia Pacific strategy and delivery of the audit (internal, contracted and vendor) and of the customer audit / inspection programs;
  • and, the delivery of commitments made to clients in quality agreements. This position is responsible for :

  • Providing strategic direction, delivery & oversight of the Asia Pacific audit & inspection function;
  • Driving proactive compliance excellence through execution of key audit / inspection activities, identifying areas of opportunity, appropriate escalation and messaging as well as trending and communicating in governance forums
  • Partnering with senior clinical research leadership to ensure effective inspection preparedness programs are implemented and to assure customer satisfaction
  • Partnering with global Regulatory and Quality Assurance leaders across business units to drive consistent QMS implementation and roll out of related global initiatives
  • Providing regulatory compliance and quality assurance advice, guidance and support to internal clinical development study teams and functions and assuring quality agreements made to clients are fulfilled.
  • Collaborating with internal stakeholders for proactive interactions and quality management
  • Representing Covance in industry quality forums.
  • A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
  • Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable
  • Typically 10+ years in a clinical trial regulatory environment with extensive experience in Good Clinical Practice (GCP roles)
  • Proven experience interpreting new / updated regulations, facilitating assessment on impact on business / QMS for adoption
  • Ability to effectively cast / communicate quality strategy to internal parties
  • Ability to network within the global QA organization to drive consistent global QMS implementation / maintain global connectivity
  • Ability to distill / communicate critical information
  • Experience and ability to effectively lead QA teams / staff in multiple geographic locations
  • Wide experience working in various cultural settings / ability to tailor communication approaches for effective / impactful collaboration
  • GCP consultation skillsets for multidisciplinary leaders and teams to drive strategic business process improvement initiatives
  • Desirable :

  • Experience leading / engagement in regional pharmaceutical industry GCP forums
  • 2021-04-09 13 : 06 : 29

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