Sr. IT Quality Control Specialist - Remote

Overview

It’s More Than a Career, It’s a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.

Our Mission:
People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.

Senior IT Quality Control Specialist oversees quality control and assurance of software, process, and data integrity validation processes. This position provides guidance and support to operational teams within Sarah Cannon Research Institute to ensure compliance with GxP, 21 CFR Part 11, and regulatory requirements. You will work closely and effectively with Global Quality and Education, IT QC Specialists, Validation Specialists, Business Owners, Product Owners, and Product Analysts.

This is a remote position based in the US; relocation assistance and visa sponsorship are not available.

• Provides expert guidance to research operations and IT teams on interpreting corporate and regulatory requirements (standards, policies, and procedures) related to software validation, quality management, and GxP compliance, and oversees quality activities supporting software, process, and data integrity validation.
• Reviews validation lifecycle documentation—including validation assessments, 21 CFR Part 11 evaluations, system validation plans, risk management plans, and validation summary reports—to ensure completeness, accuracy, and alignment with SOPs, corporate policies, standards, and applicable regulations.
• Delivers quality oversight throughout the preparation, execution, data analysis, and reporting phases of IQ, OQ, and PQ protocol development and execution.
• Conducts or supports scheduled periodic reviews of system documentation to maintain ongoing compliance with SOPs, corporate policies, standards, and regulatory expectations.
• Performs quality review and approval of change control documentation for changes impacting validated systems and/or processes.
• Other duties as assigned

• Bachelor's Degree highly preferred; work experience may be substituted for education
• 3-5+ years' work experience in a clinical research, life sciences, or CRO focused in FDA GxP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines.
• Experience should include industry and international standards for software quality such as GAMP V, PIC/S, ICH, etc.
• Experience should include pharmaceutical, biologics, CRO, and/or medical device industry 21 CFR Part 11 requirements and software validation principals.
• Exceptional time management and organizational skills, and experience working as part of a cross-disciplinary team and relating to a diverse number of coworkers.

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today.

SCRI’s research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across…