The Sarah Cannon Research Institute (SCRI) is hiring a Senior Clinical Quality Assurance Analyst. In this role, you will support technology solutions provided by Genospace, ensuring compliance with SOPs, FDA guidelines, ICH-GCP standards, and other regulatory requirements. You will be a key contributor to our mission of advancing the fight against cancer, playing a critical part in maintaining a robust Quality Management System, monitoring key metrics, and investigating quality issues.
What You'll Do
- Lead Research Quality activities to ensure adherence to policies, procedures, and regulations.
- Contribute to the development and maintenance of policies, procedures, and controlled documents.
- 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.
- Serve as a key subject matter expert and point of escalation for 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.
What We're Looking For
- A Bachelor’s degree in Science, Engineering, Life Sciences, Clinical Research, Quality Assurance, or a related field.
- 7+ years of progressive experience in clinical research quality assurance or regulatory monitoring.
- 5+ years of quality assurance and oversight of clinical software.
- Proficiency in applying risk-based approaches to software validation.
- Recognized expertise in FDA guidelines and ICH-GCP principles.
- Proven ability to influence and achieve results through collaboration in a matrixed environment.
- A strong understanding of compliance frameworks and risk-based quality management.
Nice to Have
- An advanced degree.
Benefits & Compensation
- A Total Rewards package with comprehensive benefits to support physical, mental, and financial well-being.
- A competitive compensation package determined by performance, experience, skills, equity, and market evaluations.
- Other compensation, such as an annual bonus or long-term incentive opportunities, may be offered.
Work Mode
This is a fully remote position for candidates located within the United States.
Sarah Cannon Research Institute is an equal opportunity employer and values 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.
