Director Quality Assurance

Location
Salt Lake City, Utah
Posted
May 02, 2021
Ref
2951116
Required Education
Bachelors Degree
Position Type
Contract

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 is a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, data science, and engineering, with the goal of radically improving the lives of patients and industrializing drug discovery. Central to our mission is the Recursion Operating System, or Recursion OS, that combines an advanced infrastructure layer to generate what we believe is one of the world’s largest and fastest-growing proprietary biological and chemical datasets and the Recursion Map, a suite of custom software, algorithms, and machine learning tools that we use to explore foundational biology unconstrained by human bias and navigate to new biological insights which may accelerate our programs. We are a biotechnology company scaling more like a technology company. Recursion is proudly headquartered in Salt Lake City. 

Learn more at www.recursion.com, or connect on Twitter and LinkedIn.

Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status or any other characteristic protected under applicable federal, state, or local law.