Senior Clinical Quality Assurance Analyst
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Job Description
Sr Clinical Quality Assurance Analyst at Sarah Cannon Research Institute ensuring compliance with SOPs and regulatory standards in oncology research. Leading quality assurance initiatives and supporting technology solutions in a remote setting.
Responsibilities:
- Support technology solutions provided by Genospace ensuring compliance with SOPs, FDA guidelines, ICH-GCP standards, and applicable regulatory requirements.
- 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.
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.
Benefits:
- Total Rewards package includes comprehensive benefits to support physical, mental, and financial well-being.
- Competitive compensation package determined by performance, experience, skills, and market evaluations.
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