Sr. IT Quality Control Specialist - Remote US

Sarah Cannon Research Institute • Nashville, TN

11d • Remote

About The Position

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. Our Senior IT Quality Control Specialist oversees quality control and assurance of software, process, and data integrity validation processes. This position p rovides 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 w ork 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. About Sarah Cannon Research Institute 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 the U.S. Please click here to learn more about our research offerings. We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here . As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson’s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind: McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application. McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates. McKesson job postings are posted on our career site: careers.mckesson.com . We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Requirements

• 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.

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level