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

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

The Stravitz-Sanyal Institute at Virginia Commonwealth University is seeking a Senior Quality Assurance and Compliance Specialist to safeguard the technical and regulatory integrity of our world-renowned imaging and hepatology research programs. Operating at the intersection of clinical research and rigorous QC/GMP environments, the successful candidate will manage the quality lifecycle of translational imaging within our brand-new, state-of-the-art imaging research facility. This role will manage the day-to-day operational functions of the Quality Management System (QMS) and be responsible for coordinating documentation lifecycles, maintaining compliance logs, tracking training matrices, and supporting regulatory readiness across clinical research and manufacturing activities.

The Senior Quality Assurance and Compliance Specialist will oversee the standardization of research protocols and radiochemistry methods, equipment and software validation, and regulatory audit readiness, ensuring that every process meets both FDA and EMA requirements and the Institute's mission of excellence.

Reporting to the Director of Quality Assurance, this position is pivotal in ensuring that our cutting-edge molecular and imaging research is conducted within a framework of uncompromising quality and safety.

Core Responsibilities

QMS Administration and Document Control

• Maintain the QMS: Coordinate daily operations of the VCU SSI Quality Management System (QMS) to support compliance with relevant FDA regulations, GMP, and GCP guidelines.
• Standard Operating Procedure Creation: Draft and review version-controlled Standard Operating Procedures (SOPs) within the digital QMS to ensure continuous alignment with evolving FDA regulations, GxP guidelines, and institutional research frameworks.
• Documentation Lifecycle: Administer the digital documentation lifecycle, processing and routing SOPs, training records, and deviations under the direction of the QA Director.
• Workflow Coordination: Track versioning and coordinate the approval workflows for all research and manufacturing protocols, ensuring staff have active access to the most recently approved documentation.

Compliance and Regulatory Readiness

• Daily QA Operations: Execute daily Quality Assurance (QA) tasks for research activities to support regulatory compliance, data integrity, and participant focus.
• Risk and Audit Support: Maintain the established quality risk register and assist the QA Director in coordinating the internal audit schedule.
• Inspection Logistics: Provide logistical support during external audits and regulatory inspections, serving as a key coordinator for document retrieval.
• CAPA Tracking: Administer the Corrective and Preventive Action (CAPA) tracking log, monitoring timelines for open GxP deviations and compiling root-cause documentation for Director review.
• Data Integrity Audits: Conduct routine audits of electronic records and data files to ensure they adhere to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).
• Metrics Compilation: Gather, track, and measure performance data against established QA/QC CQAs, CCPs, ECs, and KPIs to help the QA Director generate quality reports for senior management.
• IT and Software Validation: Coordinate and document all planned IT system validations, software installations, and upgrades.

Staff Training, Environmental Safety Coordination, and Quality Control

• Training Matrix Management: Administer the staff training system, ensuring training tasks for new SOPs and regulatory updates are deployed, completed, and filed. Develop GxP training materials for staff as needed.
• Qualification Tracking: Maintain a real-time matrix of staff qualifications, including state licenses, current CVs, and GxP training documentation.
• Environmental Monitoring Logs: Coordinate the collection and archiving of environmental monitoring logs for ISO-classified cleanroom environments.
• Equipment and Validation Logs: Gather and file daily and weekly QC performance logs, equipment qualifications (IQ/OQ/PQ), and validation records for clinical research imaging scanners and laboratory equipment.
• Radiopharmaceutical Manufacturing: Review technical data and outputs from radiopharmaceutical batch production records and quality control tests such as purity, sterility, and HPLC, and escalate anomalous findings.
• Radiation and MRI Safety: Ensure compliance with institutional and regulatory requirements for radiation safety monitoring, ALARA, and the safe use of MRI systems in coordination with the Radiation Safety Officer (RSO) and medical physicist.
• Issue Reporting: Identify and escalate daily quality or safety anomalies to the QA Director and relevant department heads for timely resolution.

Vendor and Change Management

• Vendor Log Maintenance: Maintain the vendor management files, tracking initial qualification paperwork and scheduling ongoing performance reviews.
• Change Control Tracking: Route and track GxP-impacting change controls initiated by VCU SSI through the established approval pathway.
• Feasibility Assistance: Gather technical compliance documentation to help complete the "Quality Assurance" sections of site feasibility questionnaires for global sponsors.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Pharmacy, or a related field, or equivalent with experience
• Experience independently maintaining a QMS system.
• Solid understanding of applicable FDA regulations, GCP/GMP guidelines, and standard quality tools (CAPA, deviations, change control).
• Direct familiarity with ALCOA+, validation logs, record retention, and database entry accuracy.
• Strong organizational and communication skills, with a proven ability to collaborate across multi-disciplinary 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 with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU.

Preferred Qualifications

• Prior experience tracking quality metrics within a dedicated clinical research or cGMP environment.
• 24 years of experience in quality assurance, data coordination, laboratory science, or regulatory affairs within a clinical research, medical imaging, or cGMP environment; Experience working in an environment handling 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.

Salary Range: $60,000-$103,000 (Commensurate w/ experience & job slotting)

Benefits: All full-time university staff are eligible for VCU's robust benefits package that includes comprehensive health benefits, paid annual and holiday leave, generous tuition benefits, retirement planning and savings options, tax-deferred annuity and cash match programs, employee discounts, well-being resources, abundant opportunities for career development and advancement, and more.

FLSA Exemption Status: Exempt Restricted Position: No

ORP Eligible: No

Flexible Work Arrangement: Hybrid

University Job Title: 92523 - Open; Specialist LG 1 (25231N) - Senior Specialist LG 3 (25236N)

Each agency within the Commonwealth of Virginia is dedicated to recruiting, supporting, and maintaining a competent and diverse work force. Equal Opportunity Employer