Director of Quality Assurance - Stravitz-Sanyal Institute Liver Disease Job Virginia area,Minnesota USA,Quality Assurance

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

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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.

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…