Senior Quality Assurance and Compliance Specialist - Stravitz-Sanyal Institute for Liver Disease
Mainz, Rhineland-Palatinate, Germany · Hybrid
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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 …
Skills: Quality Management System, FDA Regulations, GMP, GCP, Standard Operating Procedures
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Mainz, Rhineland-Palatinate, Germany · On-site
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Mainz, Rhineland-Palatinate, Germany · On-site
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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 …
The specialist will manage the Quality Management System (QMS) and oversee documentation lifecycles, compliance logs, and regulatory readiness for imaging and hepatology research. They are responsible for ensuring research protocols, radiochemistry methods, and equipment validations meet FDA and EMA standards.
Requirements
Candidates must hold a bachelor's degree in Life Sciences, Chemistry, Pharmacy, or a related field. The role requires experience with QMS maintenance and a solid understanding of FDA regulations, GCP/GMP guidelines, and quality tools like CAPA and change control.
Full job description
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.
Department: Stravitz-Sanyal Institute for Liver Disease
Duties & Responsibilities:
The Stravitz-Sanyal Institute at Virginia Commonwealth University is seeking a SeniorQuality 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.
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)
We're preparing the most innovative, compassionate, and business-savvy leaders to re-imagine healthcare.
Industry
Higher Education
Company size
11-50 employees
Founded
1949
Headquarters
Richmond, Virginia
LinkedIn followers
2,674
Fortunate to be a part of a rich history of tradition while actively connected to the contemporary realms of healthcare practice, education, and research, the Department of Health Administration at VCU is a unique place to study. We are located in downtown Richmond, VA, next door to one of the nation's top academic medical centers and tertiary trauma care trauma centers. We are proud to be currently ranked 3rd best health administration program by U.S. News & World Report.
We've been dedicated to preparing our graduates for success in the ever-evolving healthcare landscape for more than seven decades. We pride our program on producing well-equipped graduates with the business savvy, political, ethical, and essential leadership skills to be an agile leader, which is paramount in a highly competitive field.
In the summer of 2019, our new, cutting-edge facility became the home to the entire College of Health Professions. This state-of-the-art building fosters a rich inter-professional learning environment, enhancing our students' educational experiences. We're proud to have the best of both worlds: a brand-new facility that retains our presence on VCU's renowned medical campus. Incorporating the robust healthcare environment that Richmond offers and the simulation-focused training culture of the CHP building, the Department of Health Administration at VCU provides a truly unique and dynamic place for students to study.
This strategic location provides our faculty and students invaluable exposure to multidisciplinary healthcare leadership practices. From engaging in specialized research projects to exploring innovations in healthcare organization and delivery, our students have unparalleled opportunities to grow and thrive.
Offices: 900 E Leigh St, Richmond, Virginia 23298, US
health care leadershiphealth administrationhealth services organization and researchhealth equityhealth disparitiesand healthcare finance
We're preparing the most innovative, compassionate, and business-savvy leaders to re-imagine healthcare.
Industry
Higher Education
Company size
11-50 employees
Founded
1949
Headquarters
Richmond, Virginia
LinkedIn followers
2,674
Fortunate to be a part of a rich history of tradition while actively connected to the contemporary realms of healthcare practice, education, and research, the Department of Health Administration at VCU is a unique place to study. We are located in downtown Richmond, VA, next door to one of the nation's top academic medical centers and tertiary trauma care trauma centers. We are proud to be currently ranked 3rd best health administration program by U.S. News & World Report.
We've been dedicated to preparing our graduates for success in the ever-evolving healthcare landscape for more than seven decades. We pride our program on producing well-equipped graduates with the business savvy, political, ethical, and essential leadership skills to be an agile leader, which is paramount in a highly competitive field.
In the summer of 2019, our new, cutting-edge facility became the home to the entire College of Health Professions. This state-of-the-art building fosters a rich inter-professional learning environment, enhancing our students' educational experiences. We're proud to have the best of both worlds: a brand-new facility that retains our presence on VCU's renowned medical campus. Incorporating the robust healthcare environment that Richmond offers and the simulation-focused training culture of the CHP building, the Department of Health Administration at VCU provides a truly unique and dynamic place for students to study.
This strategic location provides our faculty and students invaluable exposure to multidisciplinary healthcare leadership practices. From engaging in specialized research projects to exploring innovations in healthcare organization and delivery, our students have unparalleled opportunities to grow and thrive.
Offices: 900 E Leigh St, Richmond, Virginia 23298, US
health care leadershiphealth administrationhealth services organization and researchhealth equityhealth disparitiesand healthcare finance