|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.