Associate Director, Clinical Quality Assurance

 

The Opportunity:

Our client has entered into a billion dollar collaboration with two highly regarded and pharma companies in the industry.  They are harnessing significant breakthrough technology to discover, develop, and commercialize novel therapeutics for serious unmet medical needs and are currently working on several indications in Phase 2 and 3.

Culturally, they pride themselves as a true R&D biotech with a high level of passion, innovation, and commitment to science and excellence.  Their leadership team includes proven scientists and physicians from the top commercial drug companies in the world.  With financing already in place, there are decades of growth ahead for this company.  

This is a rare opportunity to join a world-class organization and lead the Clinical Quality Assurance for the largest global clinical trial, currently in 117 countries.  The successful candidate will report into the Executive Director and will play a crucial role as they position their lead asset for commercialization.   

Key Responsibilities:

    • Provide leadership and guidance to the Clinical Development team on GCP compliance
    • Serve as primary interface and lead inspection readiness efforts for internal/external audits
    • GCP expert; provide advice/interpretation to clinical teams and develop CQA policies and SOPs
    • CRO/vendor oversight; ensure compliance with investigators and direct post-audit response efforts
    • Evaluate potential risks of compliance deficiencies and facilitate continuous improvement processes

          Key Requirements:

            • 5 – 10 years overseeing Quality Assurance
            • Strong knowledge of the Code of Federal Regulation and ICH Guideline
            • Proven ability to manage CRO/vendors

              Interested candidates may submit their resumes in strict confidence to:

              Angel M. Luisser @  aluisser@marcusassoc.com

              Marcus & Associates | Life Sciences & Healthcare

              Executive Search, Interim Services, & Consulting

              Cell: 330.749.1988 (Call or Text)