Advertising Summary: Virginia Commonwealth University (VCU)
School of Medicine is a premier academic medical center located in
the heart of Richmond. Accounting for almost half of VCU’s
sponsored research, the School of Medicine is internationally
recognized for patient care and education. Virginia Commonwealth
University is an equal opportunity employer.
https://vcujobs.com/why-richmond
Unit: School Of Medicine MBU
Department: Stravitz-Sanyal Institute for Liver
Disease
Duties & Responsibilities:
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:
Minimum 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.
- 2–4 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)
