Senior Quality Assurance Specialist United Theranostics Bethesda, MD Job Details Full-time $115,000 - $130,000 a year 1 day ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Qualifications Policy & process development Bachelor's degree Attention to detail Quality audits FDA regulations Full Job Description Senior Quality Assurance Specialist United Theranostics |

Clinical Research & Precision Oncology Work Arrangement:

Remote with travel to company locations

Travel:

Regular travel to United Theranostics locations is expected United Theranostics is expanding access to molecular imaging and radiopharmaceutical therapy, bringing innovative precision cancer care closer to patients in their communities. We are seeking a Senior Quality Assurance Specialist to help build the quality foundation that will support our continued growth and expansion. The Opportunity This is a high-impact senior individual contributor role with responsibility for quality oversight across all United Theranostics locations. You will serve as an independent quality partner to clinical research, regulatory, and operational teams, helping establish strong processes, controls, and standards that support growth while maintaining high standards of quality, compliance, and patient safety. You will have a meaningful role in identifying risks, strengthening systems, improving processes, and building the tools and practices needed to support a growing clinical research program and expanding network of locations. What You'll Do Lead internal audits, quality reviews, spot checks, and inspection-readiness assessments across locations. Evaluate clinical research and regulatory processes and documentation for compliance, accuracy, and completeness. Identify quality and regulatory risks and recommend practical corrective actions. Manage findings, CAPAs, and remediation activities through resolution and assess effectiveness. Conduct mock audits and support Sponsor audits, FDA inspections, and IRB reviews. Review essential clinical research documentation, including training records, delegation logs, investigator qualifications, IRB documentation, and safety reporting. Monitor compliance with FDA regulations, GCP, IRB/IEC requirements, Sponsor requirements, and internal procedures. Develop and improve quality controls, procedures, audit tools, and inspection-readiness processes. Identify trends and systemic issues and partner with teams to drive sustainable improvements. Establish consistent quality practices across locations as the organization grows. Provide quality and regulatory expertise and guidance to clinical research and operational teams. Travel to company locations as needed to conduct audits, assessments, training, and other quality activities. What You'll Bring Bachelor's degree in life sciences, healthcare, clinical research, regulatory affairs, or a related field preferred. Significant experience in clinical research, regulatory affairs, quality assurance, or a related field. Experience with audits, quality reviews, compliance assessments, monitoring, CAPA, or inspection readiness. Strong knowledge of FDA regulations and GCP. Excellent analytical, organizational, and communication skills. Strong attention to detail and sound judgment. Ability to work independently and effectively across multiple functions and locations. A builder's mindset and interest in creating scalable quality processes in a growing organization. Willingness and ability to travel to United Theranostics locations as needed. Why United Theranostics? This is more than a quality assurance role. You will help build the foundation that enables United Theranostics to scale. As we expand our clinical research capabilities and geographic footprint, the quality systems, processes, and controls you help establish will become an important part of how we grow. You will have the opportunity to influence how quality is built into our organization, work closely with clinical, regulatory, and operational leaders, and make a visible impact on the future of a growing precision oncology company.

Pay:

$115,000.00 - $130,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance Application Question(s): How many years of experience do you have in clinical research quality assurance, regulatory affairs, or a related quality/compliance role? or a related quality/compliance role? Briefly describe your experience with clinical research audits, CAPAs, GCP compliance, or inspection readiness. Are you able to travel to United Theranostics locations as needed for audits, quality reviews, and oversight? If yes, approximately what percentage of travel are you comfortable with? What is your desired salary range for this position?

Work Location:

Hybrid remote in Bethesda, MD 20811