Sr Clinical Quality Assurance Analyst - Remote US

Sarah Cannon Research Institute

8d•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 Sr Clinical Quality Assurance Analyst is responsible for supporting technology solutions provided by Genospace ensuring compliance with SOPs, FDA guidelines, ICH-GCP standards, and applicable regulatory requirements. Key responsibilities include supporting the Quality Management System, contributing to the development of risk-based quality processes, monitoring key quality metrics and indicators, and assisting with quality issue investigations and escalations. The individual will also support audit and inspection readiness and interface with regulatory agencies. This is a remote position based in the US; relocation assistance and visa sponsorship are not available.

Requirements

Bachelor’s degree in Science, Engineering, Life Sciences, Clinical Research, Quality Assurance or related field required; advanced degree preferred.
7+ years of progressive experience in clinical research quality assurance or regulatory monitoring with demonstrated expertise in leading complex quality initiatives.
5+ years of quality assurance and oversite of clinical software.
Proficient in applying risk-based approaches to software validation, ensuring compliance with regulatory requirements and industry expectations.
Recognized expertise in FDA guidelines, ICH-GCP principles, and applicable regulatory requirements.
Proven ability to influence and achieve results through collaboration in a matrixed environment.
Strong understanding of compliance frameworks and risk-based quality management.

Responsibilities

Lead and support Research Quality activities to ensure adherence to policies and procedures, ICH-GCP, FDA guidelines, and applicable local/federal regulations.
Contribute to the development and maintenance of policies, procedures, and controlled documents for Research Quality and supporting business units.
Assist in implementing risk-based quality support structures and tools to monitor compliance and performance.
Deliver training on quality assurance initiatives, regulatory compliance, and industry best practices.
Foster a culture of continuous improvement, patient safety, and data integrity.
Provide leadership in managing and sustaining robust document and change control programs.
Lead research quality processes to ensure compliance with SOPs, ICH-GCP, and local/federal regulations.
Serve as key subject matter expert and point of escalation with internal and external customers on all investigations and quality related issues.
Assist with preparation for external audits, inspections, and quality oversight activities.
Support communication with sponsors and regulatory agencies as directed.
Contribute to inspection readiness activities and maintain compliance documentation.
Other duties as assigned