Director of Quality Assurance - Stravitz-Sanyal Institute for Liver Disease

Director of Quality Assurance - Stravitz-Sanyal Institute for Liver Disease

• 45002112
• 907 Floyd Avenue, MCV Main Campus, Virginia, United States, 23284
• Research
• Staff
• School Of Medicine MBU

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Advertising Summary:

Unit: School Of Medicine MBU

Department: Institute for Liver Disease

Department 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

Duties & Responsibilities:

The Stravitz-Sanyal Institute at Virginia Commonwealth University is seeking a Director of Quality Assurance (QA) to lead 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 demands a high level of expertise in ALCOA+ data integrity principles, GxP, and the implementation and maintenance of a validated QMS to support Phase I-III clinical trials and radiopharmaceutical manufacturing. The Director of QA will oversee the standardization of research protocols and radiochemistry methods, equipment performance verification, and regulatory audit readiness, ensuring that every process meets both FDA requirements and the Institute's mission of excellence. 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 Governance and Oversight
• Design, implement, and maintain the VCU SSI Quality Management System (QMS) to ensure compliance with relevant FDA regulations and GMP and GCP guidelines.
• Serve as the primary owner of the QMS, managing the digital documentation lifecycle including but not limited to SOPs, training records, and deviations.
• Manage the versioning and approval workflows for all research and manufacturing protocols, ensuring that staff are always utilizing the most recently approved documentation.
• Compliance and Regulatory Readiness
• Develop and lead the Quality Assurance (QA) function for all research activities to ensure regulatory compliance, data integrity and participant focus.
• Lead the quality planning process to define the quality strategy in alignment with company goals and objectives.
• Implement a risk-based system to ensure oversight and monitoring of GxP related activities in agreement with ICH Q9. Maintain a quality risk register.
• Lead the implementation of and oversee the execution of an efficient internal audit schedule with a focus on continuous quality improvement and regulatory compliance.
• Act as the primary point of contact for external auditors and host regulatory inspections.
• Implement a validation management plan to ensure GxP equipment, software and processes are fit for purpose and meet regulatory expectations
• Manage the Corrective and Preventive Action (CAPA) program, ensuring GxP deviations are investigated appropriately to identify root-cause to prevent recurrences.
• Conduct periodic audits of data and electronic records to ensure they are Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Available (ALCOA+).
• Act as an internal consultant and key point of contact for all GxP compliance issues, queries and guidance.
• Maintain knowledge and awareness of developments in applicable global GxP pharmaceutical and research regulations and guidance. Assess their impact for the Institute and initiate changes to processes and procedures as appropriate.
• Establish and measure performance against QA/QC CQAs, CCPs, ECs, and KPIs. Generate and present quality reports, metrics, and performance summaries to senior management.
• Work cross functionality to foster a quality culture and promote continuous improvement across the organization.
• Staff Training and Environmental Safety
• Implement and manage a system of training to ensure that all staff are trained on SOPs, regulatory requirements, and quality systems.
• Maintain a real-time matrix of staff qualifications, including state licenses, CVs, and GxP training documentation.
• Ensure effective deployment of environmental monitoring programs and maintenance of ISO-classified cleanroom environments.
• Manage and monitor compliance with equipment qualification (IQ/OQ/PQ), process validation, and cleaning validation.
• Monitor daily and weekly QC performance logs for the clinical research imaging scanners and laboratory equipment, ensuring alignment with manufacturer specs and research-grade performance.
• Assess the impact severity for issues affecting quality or safety, and work with department heads to ensure timely resolution.
• Vendor and Change Management
• Establish and oversee the vendor management system, including the initial qualification and ongoing review of vendors utilized by the Institute.
• Assess and document complaints and deviations to ensure adequate action is taken to rectify issues with the aim to prevent recurrence.
• Assess and manage GxP-impacting changes that are initiated by VCU SSI.
• Oversee the validation procedures for new software and/or equipment upgrades.
• Complete the "Quality Assurance" portion of site feasibility questionnaires for global sponsors, demonstrating the Institute's compliance with relevant regulatory requirements.

Qualifications:

Minimum Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Pharmacy, or a related field. Master's or advanced degree preferred.
• 5+ years of experience in quality management and/or regulatory affairs in a research or cGMP environment.
• Significant experience in development, manufacturing and quality aspects of sterile pharmaceuticals, preferably including radiopharmaceuticals.
• Comprehensive understanding of applicable FDA and EMA regulations and how to manage them effectively.
• Experience with quality tools and systems, including CAPA, deviations, change control, and audit processes.
• Experience with risk management and root cause analysis.
• Experience in validation requirements for systems and processes used within a GxP environment.
• Experience with interactions with regulatory agencies, (FDA, EMA and/or national EU agencies) including inspections, scientific meetings and responding to review questions.
• Strong communicator with demonstrated ability to be a mentor for compliance requirements and work effectively within a multi-disciplinary environment.
• Skilled in root cause analysis and implementing effective corrective actions.
• Ability to design and implement training programs that equip professionals to operate effectively within regulatory, quality, and operational frameworks.
• 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

• Experience in the design, implementation and operation of Quality Management Systems.
• A strong background in the application of molecular imaging (PET, MRI) to clinical research.
• Knowledge of GLP and preclinical research experience is a plus.
• More than 8 years experience in nuclear medicine, radiopharmacy, or GMP pharma preferred.
• Preferred certifications include: board certification (e.g., nuclear medicine technologist, medical physicist), radiopharmacist credentials, and/or training that is aligned with the FDA and Nuclear Regulatory Commission rules.

Salary Range: $75,000-$135,000 (Commensurate with Experience)

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: Yes

Flexible Work Arrangement: Hybrid

University Job Title: 3291B - Administrator RS Base