QMS Process Owner (contractor)

The Impact You’ll Make

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. Come join us in our mission to decode biology to radically improve lives, while doing the most impactful work of your life. 

In this role, you will:

• Build a robust framework for the development, deployment, and continuous improvement of QMS processes such as Procedures and Internal training programs,Incident, CAPA, and Change Control, and vendor qualification programs while ensuring alignment with regulatory requirements and aiming for operational excellence.  
• Lead the design and execution of cross-functional training initiatives to promote consistent quality management practices across global teams. 
• Create and maintain a compliant Quality Vendor Management system to ensure that vendors meet regulatory requirements, Recursion’s standards, and manage risk effectively. 
• Collaborate across Recursion to drive process optimization, ensuring all staff are trained and compliant with evolving standards, thus fostering a proactive culture of quality throughout the organization.

Working 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 

Reporting to the Director of Quality Management Systems, you will be joining a rapidly growing Quality Assurance team at Recursion that includes CMC QA, GCP QA, GLP QA, and QMS Optimization. As a member of the QMS Optimization team, you will be focused on supporting and expanding Recursion’s record management program through deep collaboration across multiple departments. 

The Experience You’ll Need

• Bachelor’s or Master’s Degree in scientific or technical discipline. 
• 7+ years of relevant Quality experience, in a biotech/pharmaceutical setting.
• Experience should include overseeing core quality systems, such as, Incident, CAPA, and Change Control programs. Hands on experience with leading investigations, applying various methods of root cause identification, successful application of changes and cross-functional incident resolution.
• Experience should include overseeing core quality systems, such as Audit Management, SOP Development, and Vendor Qualification. Hands on experience with qualifying vendors and audit facilitation. 
• Experience should include overseeing core quality systems, such as, Document Management, SOP Development, and Training Management. Hands on experience with implementing training matrices, creating training content and managing document revisions.
• Strong project management skills with ability to manage multiple projects and execute in adherence to timelines.
• In-depth knowledge of relevant regulations, examples include FDA 21 CFR Part 11, FDA 21 CFR Part 211, ISO 9001, ICH guidelines, and other GxP requirements (GMP, GCP, GLP).
• Excellent cross-functional collaboration, interpersonal, verbal, and written communication skills.
• Demonstrated success in managing audits, regulatory inspections, and compliance with international regulations (FDA, EMA, MHRA).
• Demonstrates sound analytical and problem-solving abilities to resolve complex issues that involve numerous components.
• Familiarity with Business Tools preferred: Content Management Systems (CMS), electronic Quality Management Systems (eQMS), Document Management System (DMS), Microsoft Office Suite, Google Workspace, Slack, Learning Management System (LMS)
• Able to operate in a dynamic, fast-growing biotech company with aggressive timelines and the ability to flex between setting strategic directions and jumping in to get the work done