May 19, 2021

Director Quality Assurance

  • Recursion
  • Salt Lake City, UT
Full time Quality

Job Description

Recursion is a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, data science and engineering to radically improve the lives of patients and industrialize drug discovery. Our team is working to solve some of the hardest, most meaningful problems facing human health today. Come join us in our mission to decode biology to radically improve lives, while doing the most impactful work of your life. The Impact You'll Make Collaborate with the Clinical Operations team, CROs and sites to effectively and efficiently set up the overall GCP oversight programs Develop and implement GCP quality oversight systems through development of standard operating procedures (SOPs) that follow 21 CFR Part 50, 56 and 312 along with ICH E6 and other relevant guidance documents Lead efforts to implement and manage a Quality Management System (QMS) Perform CRO supplier risk assessments, audit plans and annual CQA audit plan Manage GCP and GLP compliance audits, including clinical investigator sites, contract research organizations (CROs) and contract clinical laboratories to determine compliance status and identify compliance risks Conduct QA reviews of essential Clinical Development documents (e.g. protocols, informed consents, investigator brochures, clinical study reports, etc.) and maintain CQA confidential files and SOPs The Team You'll Join As a Director of Quality Assurance, you will initially report to the Senior Director of Clinical Operations and lead the development of a Quality department and implementation of a Quality Management System (QMS) for Recursion. You will be joining a dynamic team of four and looking to grow considerably in 2021. You will continue to build out your team as needed to support the growth of the organization and play a key role in the strategic planning for quality management across all departments. The Experience You'll Need Bachelor's Degree in a scientific or related discipline, advanced degree preferred 10+ years of experience in a GCP quality role, with at least 3 years leading the GCP function Comprehensive knowledge of and ability to interpret and apply GCP, GLP, EU, FDA and ICH regulations and guidelines Experience in GCP audits either an auditor or hosting regulatory inspections and performing inspection readiness planning activities Experience with Quality Systems (e.g. deviations, investigations and CAPA programs) Demonstrated problem-solving skills and the ability to clearly communicate complex issues, observations and resolutions to management The Benefits/Perks You'll Enjoy 100% Coverage of health, vision, and dental insurance premiums 401(k) with generous matching (immediate vesting) Stock option grants Two one-week paid company closures (summer and winter) Flexible vacation/sick leave Generous paid parental leave (including adoptive) Onsite daycare facility* Commuter benefit and vehicle parking to ease your commute* Complimentary chef-prepared lunches and well-stocked snack bars* Monthly fitness/wellness stipend One-of-a-kind 100,000 square foot headquarters complete with a 70-foot climbing wall, showers, lockers, and bike parking* Subject to change for remote-based employees during the COVID-19 pandemic More About Us Recursion's mission is to decode biology to radically improve lives. Unraveling the exceptional complexity of biological systems and delivering the next generation of biotherapeutics at unprecedented speed and scale can only be achieved by bridging life science and technology. Recursion is the leader in digital biology, and has built the world's most advanced ultra-high throughput wet-lab and machine learning platform. Recursion's ability to generate proprietary, high-dimensional, multi-modal and relatable datasets of human cellular biology at massive scale, and apply advanced machine learning approaches to reveal novel biological relationships, has resulted in a proven, target-agnostic drug-discovery engine. 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.

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