The Director of Quality Assurance will establish the vision and implement the associated strategy for the Quality Assurance function at Recursion. 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 HQ. The role will also require travel to partner sites.
THE PROBLEMS YOU’LL SOLVE
Recursion 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.
WHAT WE DO
We start with various human cell types in our automated laboratory, where we perturb biology 100,000 different ways each week (e.g. model a disease of interest, add a chemical compound, or some combination of those). We image the resulting cells using high throughput microscopy, resulting in about 2 million new images (or greater than 20 terabytes of data) each week. These data are analyzed using computer vision and machine learning methods that help us measure how cell morphology changes in subtle ways in each biological context. We can answer direct questions (e.g. are there compounds that rescues a disease-specific set of morphological changes), and over time as our dataset has increased, we can ask more complex questions across biology.
From the outset, our approach is agnostic to preconceived notions and dogma in biology, enabling Recursion to operate in novel target space. In order to move the discovery and development process more quickly and with higher confidence, we are expanding this platform to enable us to use our image-based dataset to make predictions about biological pathways, mechanism and how each potential therapeutic will perform in later IND-enabling studies, including ADME, Tox, etc. We are also evaluating what additional high-dimensional biological datasets could extend our predictive capacity with the aim to extend our predictive capabilities and further accelerate drug discovery and development.
Recursion is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. Recursion strictly prohibits and does not tolerate discrimination against applicants because of race, color, religion, creed, national origin or ancestry, ethnicity, sex, pregnancy, gender (including gender nonconformity and status as a transgender individual), age, physical or mental disability, citizenship, past, current, or prospective service in the uniformed services, or any other characteristic protected under applicable federal, state, or local law.
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
Recursion Pharmaceuticals, a Salt Lake City-based emerging biotech, combines experimental biology, automation, and artificial intelligence in a massively parallel system to quickly and efficiently identify treatments for diseases utilizing massive, data-rich image sets generated in house. The company’s tech-first approach will enable treatments for diseases in a fraction of the typical timeframe and at a fraction of the cost.