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Associate Director, CMC Quality Assurance

Employer
Recursion
Location
Working from home
Start date
Nov 30, 2022

View more

Discipline
Quality, Quality Assurance, Science/R&D, CMC
Required Education
Bachelors Degree
Position Type
Contract
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Job Details

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

The answer was to design our Quality Assurance 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 not conducting business in a manner described as ”this is how 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 how it’s always been done” mentality, you will have the opportunity to work with the Quality Assurance team and our partners to influence the way that we support compliance at both contract manufacturing/testing organizations 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 CMC Quality Assurance team member at Recursion, you’ll directly accelerate the timeline of getting drugs into the hands of patients who need them.  

 

The Impact You’ll Make 

    Drives execution and innovation in the CMC Quality Operations program in support of pharmaceutical GMP manufacturing, testing, and release activities. You will support change control review; deviations and OOS review; regulatory/IND impact assessments; and drug product and drug substance batch record review activities.  Supports collaborative and successful partnerships with CDMOs and other Vendors through participation in vendor qualification evaluations; reviewing/creating Quality Agreements; and assuring adequate documentation of manufacturing activities.  Partners with CMC Operations and Quality Assurance team members to drive quality initiatives and continuous improvement, in support of an effective Quality Management System and high-quality outcomes across the organization. 

The Team You’ll Join  

    While reporting to the Director CMC Quality Assurance, you will be joining a growing Quality Assurance team at Recursion, where you will partner closely with the Development and CMC teams to assure the phase-appropriate and quality development and manufacture of drugs in support of our rapidly-expanding clinical programs. You will bring your Quality expertise and mindset to act with urgency and agility to help build a next-generation biopharmaceutical company. 

The Experience You’ll Need 

    4+ years in a pharmaceutical GMP environment with practical knowledge in cGMPs, Health Authority Regulations, and Quality Systems   Bachelor’s degree in a Science/Technology/Engineering/Mathematics discipline   Demonstrated ability to review change controls, deviations, and batch records to confirm quality and identify compliance with requirements and standards  CMC Operations experience with technical knowledge of Drug Substance, Drug Product, or Finished Goods processes for clinical-stage products  Ability to manage risks and execute against strategic and tactical objectives Ability to work cross functionally

 

#LI-CP1
#LI-Remote

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. 

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. 

Company

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.

Recursion is proudly headquartered in Salt Lake City, Utah with offices in Toronto, Montreal and Milpitas, California. We're working to solve some of the most meaningful problems facing human health today. Come do the most impactful work of your career at a company that prioritizes belonging, collaboration and career development.

Find Us
Website
Phone
801-587-1629
Location
41 S. Rio Grande Street
Salt Lake City
Utah
84101
US
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