Sr IT Quality Control Specialist Remote US

Its More Than a Career Its 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.

The Senior IT Quality Control Specialist oversees quality control and assurance of software process and data integrity validation processes. Provides guidance and support to operational teams within Sarah Cannon Research Institute to ensurecompliance with GxP 21 CFR Part 11 and regulatory requirements. Works 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.

What our Sr IT Quality Control Specialist is responsible for:

• Provides guidance to research operations and IT on the interpretation of corporate and regulatoryrequirements (standards/policies/procedures) related to software validation quality managementand GxP and oversees quality activities related to software process and data integrity validation.

• Provides review of validation life cycle documents including validation assessments 21 CFR Part 11assessments system validation plans risk management plans and validation summary reports inadherence with SOPs corporate policies standards and government regulations to ensurecompleteness and accuracy.

• Provides quality guidance through the cycle of preparation execution data analysis and report writingfor IQ OQ and PQ protocols.

• Conducts and/or assists with periodic review of system documentation according to defined scheduleto ensure continued compliance with SOPs corporate policies standards and government regulations.

• Provides quality review and approval of change request documentation related to changes that impactvalidated systems and/or processes.

• other duties as assigned

Qualifications for success include:

• Bachelors Degree required; professional qualified experience may be substituted for education.

• Direct experience in QA/QC role overseeing computerized systems validation

• Experience in GCP clinical space such as CRO or SMO is highly preferred

• 5 years professional work experience in a clinical research biotech or pharmaceutical environment focused in FDA GxP requirements for systems 21 CFR Part 11 and FDA software validation guidelines.

• Experience and knowledge of EU regulations e.g. Annex 11 is preferred.

• Knowledge of industry and international standards for software quality such as GAMP V PIC/S ICH etc.

• Knowledge of pharmaceutical biologics CRO and clinical sites 21 CFR Part 11 requirements and software validation principles.

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI) is one of the worlds 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 2022 SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 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 in the past decade. SCRIs research network brings together more than 1300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20 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. Thats 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 addition to base pay other compensation such as an annual bonus or long-term incentive opportunities may be offered.

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