Manager, Quality Systems (GXP Quality Management and Training)

The Impact You’ll Make

• Build a fit-for-purpose and compliant GXP Quality Management and Training program. You’ll collaborate across GXP Operations, HR, Legal, and QA to build and implement integrated GXP Quality Management and GXP Training processes to ensure continuing maturity of our GXP quality systems.
• Oversee all aspects of the GXP Quality Management and Training processes to assure controlled distribution and access to quality management (e.g., policies and procedures) and training content. Provide governance of the processes to assure organizational and personal compliance with Recursion standards and regulatory requirements.
• Collaborate with GXP operational stakeholders to develop fit-for-purpose, streamlined, and compliant Policies and Procedures to assure consistency, efficiency, and compliance in our execution of GXP-regulated activities.
• Lead the development and delivery of effective training on all aspects of quality management through maintenance of a role-based training matrix and GXP onboarding program.
• Drive a quality-minded culture across the organization by providing sound, fit-for-purpose guidance to assure quality objectives are met.

The Team You’ll Join

• Reporting to the Senior Director, Quality Assurance, you will be the first member of Quality Systems to join a rapidly growing Quality Assurance team at Recursion, which includes Preclinical QA, Clinical QA, CMC QA, and Quality Systems. As the first QA team member with GXP Quality Management and Training expertise, you will be focused on supporting and enabling Recursion’s development programs through deep collaboration across GXP operations, HR, Legal, and QA.

 The Experience You’ll Need

• Bachelor’s degree with 6 years in a Quality Management/ Training role (with 3 years in the pharmaceutical/biotech industry)
• Knowledge of the drug development lifecycle, International Conference on Harmonization (ICH) Guidelines, and US and EU GXP regulations relating to drug development (i.e., GLP, GCP, GMP) and the use of electronic systems (i.e., 21 CFR Part 11/ Annex 11)
• Experience in coordinating, delivering, and governing effective role-based training for a diverse set of employee roles; experience in content development is a plus
• Experience in developing, maintaining, and governing fit-for-purpose, practical, and compliant policies and procedures; experience in technical writing is a plus
• Experience in implementing and maintaining electronic Learning Management Systems and Document/Content Management Systems
• Demonstrated ability to work in a multi-disciplinary using risk-based principles

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