Job Description  Associate Director, Clinical Quality Assurance

 SUMMARY:

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.

RESPONSIBILITIES:

  • 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

REQUIREMENTS:

  • 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.

 EOE