Job Description  Associate Director, Clinical Quality Assurance


Reporting directly to the Senior Director of Quality Assurance, the Associate Director, Clinical Quality Assurance will be responsible for leading the Clinical Quality function within QA department and collaborate cross-functionally with the various Mirati GXP departments to ensure GCP compliance at Mirati and Mirati’s approved vendor locations.


  • Meet the needs of QA by maintaining CQA compliance for ongoing Mirati clinical trials.
  • Maintain the GCP Audit Schedule (Internal & External)
  • Responsible for Clinical Vendor Qualifications including, Conducting External GCP Audits, Performing Audit Assessments and Authoring and/or Reviewing Audit Reports
  • Provide audit/inspection support and all quality related services as required
  • Assist Senior Director of Quality Assurance to ensure Inspection Readiness at Mirati’s approved vendor locations
  • Assist Senior Director of Quality Assurance with Mirati Partner Audits and associated Audit CAPA plans
  • Conduct GCP audits at clinical sites and CROs as needed
  • Support internal and external audits and inspections to ensure compliance with established quality assurance processes, standards, regulatory guidelines
  • Work with Regulatory to review IND submissions – ensuring compliance
  • Work with Clinical and Medical to Assess Vendor Classification Level
  • Responsible for Drafting and Maintaining Current Quality Agreements with clinical vendors
  • Ensure clinical documentation in support of Trial Master File is archived appropriately
  • Conduct QC reviews of Clinical Protocols, IBs, and IND / IMPD Amendments
  • Perform and/or coordinate periodic GCP refresher training
  • Develop, revise, implement and adhere to Quality Assurance department policies and procedures
  • Other duties, as needed


  • Bachelor’s or Master’s degree in Life Sciences field or equivalent years’ experience, with 10+ years pharmaceutical industry experience and a minimum of 8 years in Quality Assurance.
  • Previous small molecule drug experience is a strong plus
  • Established working knowledge of Good Clinical Practices and other applicable regulations (US and international, eg, EU GDPR).
  • Quality Assurance experience supporting Phase 3 clinical trials.
  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Professional demeanor and an excellent written and verbal communicator.
  • Detail oriented and well organized.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
  • Proficient in Microsoft Office suite and applications.