Senior Quality Assurance and Compliance Specialist - Stravitz-Sanyal Institute for Liver Disease

Virginia Commonwealth University (VCU) School of Medicine, a premier academic medical center in Richmond, is seeking a Senior Quality Assurance and Compliance Specialist for the Stravitz-Sanyal Institute for Liver Disease.

About the Role

The Stravitz-Sanyal Institute at VCU is seeking a Senior Quality Assurance and Compliance Specialist to safeguard the technical and regulatory integrity of its world-renowned imaging and hepatology research programs. This role operates at the intersection of clinical research and rigorous QC/GMP environments, managing the quality lifecycle of translational imaging within a brand-new, state-of-the-art imaging research facility. The position reports to the Director of Quality Assurance and ensures cutting-edge molecular and imaging research is conducted within a framework of uncompromising quality and safety.

Responsibilities

• QMS Administration and Document Control
  • Maintain the VCU SSI Quality Management System (QMS) to support compliance with FDA regulations, GMP, and GCP guidelines.
  • Draft and review version-controlled Standard Operating Procedures (SOPs) to align with evolving FDA regulations, GxP guidelines, and institutional research frameworks.
  • Administer the digital documentation lifecycle, processing and routing SOPs, training records, and deviations.
  • Track versioning and coordinate approval workflows for research and manufacturing protocols.
• Compliance and Regulatory Readiness
  • Execute daily Quality Assurance (QA) tasks to support regulatory compliance, data integrity, and participant focus.
  • Maintain the quality risk register and assist in coordinating the internal audit schedule.
  • Provide logistical support during external audits and regulatory inspections, including document retrieval.
  • Administer the Corrective and Preventive Action (CAPA) tracking log, monitoring timelines for open GxP deviations.
  • Conduct routine audits of electronic records and data files to ensure adherence to ALCOA+ principles.
  • Gather, track, and measure performance data against established QA/QC CQAs, CCPs, ECs, and KPIs.
  • Coordinate and document IT system validations, software installations, and upgrades.
• Staff Training, Environmental Safety Coordination, and Quality Control
  • Administer the staff training system, ensuring completion of training tasks for new SOPs and regulatory updates.
  • Develop GxP training materials for staff as needed.
  • Maintain a real-time matrix of staff qualifications, including state licenses, current CVs, and GxP training documentation.
  • Coordinate the collection and archiving of environmental monitoring logs for ISO-classified cleanroom environments.
  • Gather and file daily and weekly QC performance logs, equipment qualifications (IQ/OQ/PQ), and validation records.
  • Review technical data and outputs from radiopharmaceutical batch production records and quality control tests (e.g., purity, sterility, HPLC).
  • Ensure compliance with radiation safety monitoring, ALARA, and MRI safety requirements.
  • Identify and escalate daily quality or safety anomalies to the QA Director and relevant department heads.
• Vendor and Change Management
  • Maintain vendor management files, tracking initial qualification paperwork and scheduling performance reviews.
  • Route and track GxP-impacting change controls through the established approval pathway.
  • Gather technical compliance documentation to complete "Quality Assurance" sections of site feasibility questionnaires for global sponsors.

Requirements

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or a related field, or equivalent experience.
• Experience independently maintaining a QMS system.
• Solid understanding of applicable FDA regulations, GCP/GMP guidelines, and standard quality tools (CAPA, deviations, change control).
• Familiarity with ALCOA+, validation logs, record retention, and database entry accuracy.
• Strong organizational and communication skills, with a proven ability to collaborate across multidisciplinary research and clinical teams.
• Proficiency with digital document management systems, electronic data capture (EDC) tools, or spreadsheets for tracking metrics.
• Demonstrated ability to work in and foster an environment of respect, professionalism, and civility.

Preferred Qualifications

• Prior experience tracking quality metrics within a dedicated clinical research or cGMP environment.
• 2–4 years of experience in quality assurance, data coordination, laboratory science, or regulatory affairs within clinical research, medical imaging, or cGMP environments.
• Experience working with radiopharmaceuticals or sterile pharmaceutical products.
• Greenfield site development experience and/or building and implementing a QMS system.
• Clinical research and/or medical imaging experience.
• Knowledge of GLP and preclinical research standards.

Pay

$60,000–$103,000 (commensurate with experience).

Benefits

• Comprehensive health benefits.
• Paid annual and holiday leave.
• Generous tuition benefits.
• Retirement planning and savings options, including tax-deferred annuity and cash match programs.
• Employee discounts and well-being resources.
• Abundant opportunities for career development and advancement.