The Director of Quality Assurance will establish the vision and implement the associated strategy for the Quality Assurance function. In this role, you'll build a quality function from the ground up and will serve as the internal GxP expert. We are looking for someone to start in a full time contractor/consultant role and spend at least 10 days per month in Salt Lake City at our clients HQ. The role will also require travel to partner sites.
THE PROBLEMS YOU’LL SOLVE
Our Client is a next-generation pharmaceutical company using automation and artificial intelligence to transform how drugs are discovered. Our first molecule transitioned to the clinic last year and we are looking to get multiple programs—in a variety of therapeutic areas—into the clinic in the next few years; this kind of ambition provides an opportunity to think about development in a whole new light. This is where you come in.
In this role, you will establish a Quality Assurance function that applies an appropriately risk-based approach to driving assets discovered on our technology platform into the clinic. This responsibility includes the development, execution, and maintenance of risk-based audit strategies focused on internal and external Good Clinical/Laboratory/Manufacturing Practice (GxP) audits to ensure that preclinical development, clinical trials, and manufacturing activities are conducted in compliance with applicable regulations, ICH guidelines, procedures and clinical trial protocols.
The Director of Quality Assurance reports to the Chief Operating Officer and will foster a GxP compliant environment with internal and external stakeholders, deploy GxP inspection readiness plans throughout the company, and perform due diligence activities on in-licensing opportunities and provide regulatory expertise as we out-license programs.
THE EXPERIENCE YOU’LL NEED
· In-depth knowledge of the drug development process (early through late stages), trial design, data and trial management procedures.
· Experience defining and implementing procedures and quality systems which ensure compliance to GxP and regulatory standards and are appropriate for a small R&D company
· Extensive experience in and knowledge of internal and external GxP auditing and quality systems operations.
· Wide-ranging experience leading regulatory authority inspections of clinical research activities, particularly in the US and EU, but also in Rest of World regions.
· Strong knowledge of health authority submission activities for regulatory filings in USA, EU and Rest of World region.
· Current and in-depth knowledge and application of international requirements of GxP, ICH Guidelines, regulations and compliance initiatives globally applicable to the conduct of clinical trial.
· Outstanding leadership experience and mentoring skills