Manager, QMS Record Management

Summary

Join our mission to decode biology and radically improve lives at Recursion, a clinical-stage biotechnology company. As a Record Management Specialist, you will build world-class infrastructure, lead implementation, and collaborate across teams to drive quality and innovation.

Requirements

• Bachelor’s or Master’s Degree in scientific or technical discipline
• 7+ years of relevant Record Management experience, in a biotech/pharmaceutical setting
• Hands-on experience with controlled/regulated record lifecycle management, record review and approval process, access control, storage and retrieval, archival, distribution, record retention, internal record audits and regulatory compliance standards
• 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 211, FDA 21 CFR Part 11, ISO 9001, ICH guidelines, and 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

Responsibilities

• Build world-class infrastructure to enable the management of records across the enterprise as part of digital transformation initiatives
• Lead the implementation, ownership, oversight, maintenance, and execution of strategies relating to the expansion of record management systems, principles, programs, and policies across the company
• Collaborate across Recursion to drive a quality-minded, innovative culture and identify next-generation, industry-leading technologies to support our records program

Benefits

Making Salt Lake City your home base is ideal, however, we will consider remote work for this position