Associate Director, Clinical Quality Assurance (GCP)

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?” 

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 any activities that are only justified because  ”it’s 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 the answers but because they think through situations and work with their partners to find the best answers. Without a consensus-driven or “this is the way it’s always been done” mentality, you will have the opportunity to work with the QA team and our partners to  influence the way that we support compliance at both investigator sites and within Recursion.. 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 Clinical Quality Assurance(CQA)  team member at Recursion, you’ll directly accelerate the timeline of getting drugs into the hands of patients who need them. 

Hear more from the Head of Recursion’s Quality Assurance team:

The Impact You’ll Make

• Promote compliance knowledge and confidence at investigator sites.  As a member of the CQA team, you will have the opportunity to visit investigator sites approximately twice per month prior to and/or early in the enrollment process to assure understanding of quality and compliance principles as they relate to Recursion studies.
• Support the development of a risk-based, fit-for-purpose Clinical Quality System. You will be asked to collaborate across all clinical development functions to build and implement phase-appropriate and applicable quality systems to support Clinical Development activities, from study design through reporting.
• Participate as the QA representative on Clinical Study Teams.  As a member of CQA and Clinical Study Teams, you’ll serve as a CQA SME who provides risk-based compliance guidance and drives awareness about quality principles to assigned study teams. Cross-functional collaboration is key to the success of Recursion development programs.
• Assist in the development and implementation of an internal Clinical Quality Assurance program. As a member of the CQA team, you’ll collaborate with QA and Clinical Development colleagues to design and implement right-sized quality oversight initiatives to support, enable, and accelerate clinical development. You’ll maintain collaborative, integrated, and productive relationships with internal stakeholders, fellow team members, and external vendor-partners to assure appropriate sponsor oversight is maintained.

The Team You’ll Join 

• You will be joining a dynamic Quality Assurance team at Recursion, which includes Preclinical QA, Clinical QA, CMC QA, and Quality Systems. Reporting to the Senior Director, Clinical Quality Assurance, you will bring GCP expertise and creative ideas to the organization. You will be focused on supporting and enabling Recursion’s clinical development programs through deep collaboration across Recursion, including Clinical Operations, Clinical Science, Biometrics, Regulatory, and Pharmacovigilance. 

The Experience You’ll Need

• Bachelor’s degree in a life science field, or equivalent, with 5+ years in a clinical development role within the pharmaceutical/biotech industry, including 2+ years in a GCP Quality Assurance role
• Knowledge of the drug development lifecycle, including in-depth knowledge of Good Clinical Practices and International Conference on Harmonization (ICH) Guidelines relating to clinical trial conduct.
• Inspection experience preferred
• Experience in planning and conducting QA oversight activities in an outsourced environment using risk-based approaches
• Experience auditing, including direct interaction with investigators and site staff, is required
• Demonstrated ability to thrive, both strategically and tactically, in a multi-disciplinary environment using a first principles approach

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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.

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.