Senior Clinical Quality Assurance Analyst
McKesson
full-time
Posted on:
Location Type: Remote
Location: Tennessee • United States
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Job Level
Tech Stack
About the role
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical research quality assuranceregulatory monitoringrisk-based quality managementsoftware validationquality assurance oversightcompliance documentationdocument controlchange controltraining deliveryinspection readiness
Soft Skills
leadershipcollaborationcommunicationcontinuous improvementinfluencingproblem-solvingorganizational skillsattention to detailadaptabilityinterpersonal skills