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Associate Director, Clinical Quality Assurance (GCP)

Company: Recursion
Location: Salt Lake City
Posted on: January 25, 2023

Job Description:

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?"
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


Keywords: Recursion, Salt Lake City , Associate Director, Clinical Quality Assurance (GCP), Healthcare , Salt Lake City, Utah

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