Job Description  Associate Director, Quality Systems

 SUMMARY:

Reporting directly to the Director of Quality Assurance, the Associate Director, Quality Systems will be responsible for leading the Quality Systems function within QA department and collaborate cross-functionally with the various Mirati GXP departments to ensure GXP compliance at Mirati and Mirati’s approved vendor locations.  The Associate Director, Quality Systems will have the following responsibilities related to the GXP auditing, training, CAPA and document control functions.

RESPONSIBILITIES:

  • Maintain the GXP Audit Schedule (Internal & External)
  • Responsible for Vendor Qualifications including:
    • Maintain approved vendor list and schedule
    • Conduct external GXP audits, including GMP Contract Manufacturing Organizations (CMO), GLP Test Labs, and GCP Vendors (as needed)
    • Author and/or Review Audit Reports and questionnaires
    • Perform audit assessments
  • Provide audit/inspection support and all quality related services as required
  • Assist Director of Quality Assurance to ensure Inspection Readiness at Mirati and Mirati’s approved vendor locations
  • Assist Director of Quality Assurance with Mirati Partner Audits and associated Audit CAPA plans
  • Support and coordinate internal and external audits and inspections to ensure compliance with established quality assurance processes, standards, regulatory guidelines
  • Work with CMC to Assess Vendor Classification Level
  • Work with Regulatory to compile Vendor Audit information in support of US and Ex-US Submissions
  • Actively Manage the Mirati CAPA Program
  • Ensure appropriate CAPA plans are initiated and timely implementation of CAPA Program
  • Monitor Mirati Vendor Audit CAPA commitments
  • Oversee the New Employee Training Curriculum Assignment
  • Oversee the GXP (GCP/GLP/GMP) Refresher Training Programs
  • Actively manage program to ensure GXP Employees are compliant with individual SOP Training
  • Conduct and/or coordinate GXP and/or Classroom training as needed
  • Responsible for Training Tracking System
  • Maintain QA Controlled Documentation System – including SOPs, Forms, Policies and Work Instructions
  • Author and Facilitate SOP creation
  • Maintain Document Change Controls (i.e., SOP writing, including Periodic Reviews)
  • Responsible for Drafting and Maintaining Current Quality Agreements
  • Assist Clinical QA as needed (including GCP Auditing, Clinical Submission QC Reviews, etc.)
  • Ensure GXP compliance at Mirati and Mirati’s vendor locations is maintained
  • Assist with QC reviews for CMC Amendments as needed
  • 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 and NDA-level experience are a strong plus
  • Established working knowledge of Good Manufacturing Practices and other applicable regulations (US and international)
  • Quality Assurance experience supporting both development projects and commercial products.
  • 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.
  • Willing collaborator
  • 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
  • Good and thoughtful listener
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies
  • Proficient in Microsoft Office suite and applications

EOE