Director, Preclinical Quality Assurance (GLP)

Employer
Recursion
Location
Salt Lake City, Utah, United States
Posted
May 10, 2022
Ref
4123911
Required Education
Bachelors Degree
Position Type
Full time
Expect more from your next Quality Assurance role

What if Quality Assurance could be positioned as a force for supporting positive change? What if they were partners in creating positive outcomes for patients rather than the “compliance cops”? Can QA do more to help protect patients beyond auditing and annual compliance training? 

In service of Recursion’s mission to decode biology and radically improve lives, we asked ourselves, “what would it take to make QA a driver of meaningful and positive change?” 

Recursion is the clinical-stage biotechnology company industrializing drug discovery by decoding biology. Recursion leverages sophisticated machine-learning algorithms to infer biological relationships. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.

The answer was to design our QA function not as a hurdle for others to navigate or overcome, but as a partner in assuring patient safety, product quality, and data integrity across the organization. It starts with a willingness to re-examine old thinking and methodologies, rejecting blind adherence to checklists and anything that smacks of ”the way it's always been done.” 

Quality Assurance at Recursion thinks in terms of process and outcomes, and is driven by purpose. The people we hire are successful here not because they know all of the answers, but because they think through situations  to find the best answers. Without a consensus-driven or “this is the way it’s always been done” mentality, you will have direct influence on the processes we create and support. This kind of empowerment to interpret and apply the true meaning of requirements can be uncomfortable at times because it feels like working without a net. But together, side-by-side with our partners in data, science, and medicine, we’re artists and scientists for the sake of assuring patient safety, product quality, and data integrity.

You’ll be joining Recursion at an interesting time, both for the company and for the world. The global pandemic has reinforced in everyone’s mind not only the importance of therapeutics, but also the critical value that accelerating every phase of drug discovery can provide. For most, the notion that “patients can’t wait” is abstract; COVID-19 has made this concept all too real for millions, even billions, worldwide. As a preclinical quality assurance leader at Recursion, you’ll directly accelerate the timeline of getting drugs into the hands of patients who need them. 

Hear more from QA’s hiring manager:

The Impact You’ll Make

  • Build a risk-based, fit-for-purpose Preclinical Quality Assurance program. You’ll collaborate across Discovery, Translational Medicine, Development (nonclinical through clinical) and Manufacturing to build and implement an internal Quality Assurance program that supports nonclinical development capabilities, from study design through reporting.
  • Lead the development and maintenance of collaborative and productive QA2QA relationships with our vendor-partners. You’ll provide meaningful QA oversight to assure proactive and phase appropriate risk management across nonclinical development activities.
  • Collaborate with internal teams to drive a quality-minded culture within each program. You’ll serve as the Preclinical/nonclinical QA SME on multiple programs to provide sound, fit-for-purpose guidance to assure quality objectives are met and data is scientifically reliable.

The Team You’ll Join 

  • Reporting to the Senior Director, Quality Assurance, you will be the first member of Preclinical QA to join a rapidly growing Quality Assurance team at Recursion, which includes Preclinical QA, Clinical QA, CMC QA, and Quality Systems. As the first QA team member with GLP expertise, you will be focused on supporting and enabling Recursion’s early development programs through deep collaboration across Recursion, including Discovery, Translational Medicine, Preclinical Development, and Clinical Development. 

The Experience You’ll Need

  • Bachelor’s degree in a life science field, or equivalent, with 10+ years in a nonclinical role, including Discovery, Translational Medicine, DMPK, Toxicology, etc., within the pharmaceutical/biotech industry (with 5+ years in a GLP Quality Assurance leadership role)
  • Comprehensive knowledge of the drug development lifecycle, good research practices, International Conference on Harmonization (ICH) Guidelines, and US and EU GXP regulations relating to nonclinical development (i.e., GLP, GCP, GCLP, and PV)
  • Experience in planning and conducting QA activities across the development lifecycle risk-based approaches; auditing experience is a plus
  • Demonstrated ability to work in a multi-disciplinary using risk-based principles

#LI-CP1

The Values That We Hope You Share:

  • We Care: We care about our drug candidates, our Recursionauts, their families, each other, our communities, the patients we aim to serve and their loved ones. We also care about our work.
  • We Learn: Learning from the diverse perspectives of our fellow Recursionauts, and from failure, is an essential part of how we make progress.
  • We Deliver: We are unapologetic that our expectations for delivery are extraordinarily high. There is urgency to our existence: we sprint at maximum engagement, making time and space to recover. 
  • Act Boldly with Integrity: No company changes the world or reinvents an industry without being bold. It must be balanced; not by timidity, but by doing the right thing even when no one is looking.
  • We are One Recursion: We operate with a 'company first, team second' mentality. Our success comes from working as one interdisciplinary team.

Recursion spends time and energy connecting every aspect of work to these values. They aren’t static, but regularly discussed and questioned because we make decisions rooted in those values in our day-to-day work. You can read more about our values and how we live them every day here.

Recursion requires all employees to be fully vaccinated for COVID-19 prior to their first date of employment.

More About Recursion 

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 that values diversity and inclusion.  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, local, or provincial human rights legislation.