Your work will change lives. Including your own.
The Impact You’ll Make
Join our dynamic Clinical Development team as a Manager of GXP Technology Optimization, where you will play a pivotal role in partnering with IT to ensure the seamless operation and compliance of GxP computerized systems and technology platforms. In this multifaceted role, you will be accountable for ensuring users have appropriate permissions for the GXP systems in scope while also serving as a valuable resource for users seeking technical and business support, training, and guidance in system functionality. Collaborating closely with IT, you will spearhead system maintenance and enhancements to meet evolving industry standards. Additionally, your expertise will be instrumental in developing functional requirements for new technology platforms, making an indelible impact on the advancement of drug development processes. If you possess a strong grasp of GxP regulations, a knack for system operation and a passion for optimizing workflows, we invite you to contribute to our innovative and transformative endeavors in the field of clinical development.
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GxP Process Business Owner – Deliver comprehensive functional assistance and know-how to clinical development users, addressing queries related to system processes, functionality, workflows etc. Primary responsibilities include:
- Manage account creation, suspension, and termination based on departmental requirements, licensing, and training criteria for Dot Compliance. Work with IT to transition and automate this process into the IT account management process.
- For Dot Compliance, govern permissions and access to system modules, aligning with departmental needs and role specifications within the drug development pipeline. Work with IT to transition and automate this process into the IT account management process.
- Supervise and optimize workflows for GxP activities within system modules.
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GxP System Business Support – Deliver comprehensive assistance (help desk style) to clinical development users, addressing inquiries related to system functionality, processes, and workflows. Primary responsibilities include:
- Providing technical assistance to system users with questions, errors, and general help as it relates to business and QA processes in each GxP system.
- Conduct training sessions on vital processes, producing training content, and overseeing system quality assurance for training initiatives.
- Collaborate with GxP system providers to functionally enhance systems by partnering with IT, based on observed trends in functionality issues.
- Foster internal improvements of GxP systems through collaboration with Recursion IT Engineering and Infrastructure, focusing on automation and standardization.
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GxP System Compliance Support – Become a strategic partner with Recursion IT Assurance and Portfolio Management to ensure GxP Systems are current and compliant.
- Set forward regulation requirements and document them in Standard Operation Procedures for GxP processes.
- Provide QA and Regulatory compliance expertise on validation documentation.
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GxP System Project Management – As the need for new technology platforms and computerized systems within clinical development grows, serve as the leader for following the IT System/Application Onboarding process and managing the project on the Clinical Development side to facilitate bringing these technologies in house.
- Identify the need for technology and computer systems through functional requirements, user requirements.
- Work with procurement and IT to bring on selected systems.
Location:
Making Salt Lake City your home base is ideal, however, we will consider remote work for this position. We ask that remote employees commit to regular on-site visits for routine work and departmental events.
The Team You’ll Join
You will be joining a dynamic Regulatory, Quality and Innovation team, which includes Regulatory Policy & Strategy, Quality Strategy & Operations, and QMS Optimization. Reporting to the Director of QMS Optimization, you will bring computerized system expertise and creative ideas to the organization.
The Experience You’ll Need
- Bachelor’s degree in a life science field, or equivalent, with 5+ years within the pharmaceutical/biotech industry, including 2+ years working within validated systems
- Experience in planning and conducting QA oversight activities in an outsourced environment using risk-based approaches
- Experience sourcing and onboarding new technologies and computerized systems within a Quality Management System, Regulatory Management System, Clinical Trial Management System, Regulatory Information Management System.
- Demonstrated ability to thrive, both strategically and tactically, in a multi-disciplinary environment using a first principles approach.
How You’ll be Supported
- Participation in interdepartmental meetings between IT and QA provide opportunities to integrate up front
- Regular 1:1s with supervisor and colleagues provide opportunities for support and feedback
- Training on Recursion’s culture and values and our Drug Discovery & Development processes to provide insight to our unique approach and strategy for success
- Customized training program created specifically for this unique role
At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is:
- Developing: $121,000 USD
- Skilled: $134,000 USD
- Expert: $148,000 USD
To learn more about our level within levels, click here.
You will also be eligible for bonuses and equity compensation + our comprehensive benefits package for United States based candidates. The range displayed on each job posting reflects target ranges for US new hire salaries and is determined by job, level, and market factors.
During the interview selection process, you will connect with a Talent Acquisition Partner who will be your advocate and ally to ensure you receive the appropriate compensation that meets your needs for your skills, experience, and relevant education/training, while also reviewing our very competitive total rewards package.
#LI-DNI
The Values That We Hope You Share:
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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.
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We Learn: Learning from the diverse perspectives of our fellow Recursionauts, and from failure, is an essential part of how we make progress.
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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.
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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.
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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
Recursion is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. 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.
Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montreal and the San Francisco Bay Area. 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.
