Global Head, Clinical Quality Assurance

Massachusetts / New Jersey / North Carolina
United States
Our client is a life sciences company committed to harnessing and accelerating change. They have asked us to assist them in their search for a Global Head, Clinical Quality Assurance.

Major tasks and responsibilities will include:
  • Contributes to the establishment of quality assurance and control policy.
  • Ensures appropriate preparation for, management of, and responses to regulatory inspections in order to deliver the optimum outcome for customers
  • Supports QA management in identifying strategic direction and policy development.
  • Collaborates with Senior Management regarding quality/compliance and continuous improvement issues, as necessary.
  • Conducts training on Quality issues and SOP development.
  • Ensures the appropriate management of issues of potential fraud and misconduct in order that the impact to and customers is minimized as far as possible whilst ensuring regulatory expectations are met.
  • Authors QA SOPs.
  • Ensures that operating procedures, work instructions and guidelines describing the processes applied by the department are maintained up-to-date to reflect current practice and are consistent with industry standards and regulations.
  • May serve as regional QA representative to the global QA SOP taskforce.
  • Provides mentorship, interpretation, support, training, and key input to development groups for consultation and interpretation of corporate standards, and policies.
  • Hosts customer audits and participate in review of corrective action plans.
  • Recommends systems for audit, write systems audit plans and coordinate scheduling, conduct, reporting and closure of internal system audits.
  • Serves as QA liaison for assigned customers, therapeutic groups and/or functional areas, act as primary back-up for QA management of projects.
  • Conducts trend analysis of audit results and provide QA management with initial root cause analysis
  • Presents trend analysis results and QA metrics to upper management.

We seek candidates with the following qualifications:
  • Bachelor’s degree required.
  • Must have a deep understanding of the pharmaceutical research and development process, clinical research and the regulatory environment.
  • Requires the ability to influence and guide others at all levels of management.
  • Requires the demonstrated ability to lead and handle multiple responsibilities.
  • Must be articulate and define departmental needs and processes.
  • Requires the ability to establish and maintain effective working relationships with coworkers, managers and clients including coordinating timelines.
  • Travel as required.

If interested, please email your resume as a Word attachment to us. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.
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