ABOUT VGXI INC.

VGXI is a leading-edge CDMO dedicated to revolutionizing the biopharmaceutical industry with best-in-class nucleic acid-based products and services. We deliver manufacturing excellence in state-of-the-art facilities with the agility and scale to meet projects of all sizes to serve the global community of next-generation therapeutic developers.
If you are driven by innovation, fueled by scientific curiosity, and committed to making a positive impact on the global pharmaceutical community, you’ve come to the right place. We are always looking for quality-minded, team-oriented individuals who share our dedication to excellence. At VGXI, we’ve cultivated a workplace that people genuinely enjoy being a part of, and we take immense pride in the role they play in shaping our success story. We embrace a culture of quality in our products and in our people. Explore the possibilities, unlock your potential, and contribute to the future of Plasmid DNA manufacturing and precision medicine with VGXI.

SUMMARY

The Digital Quality Systems Manager is responsible for leading the implementation, integration, and lifecycle management of electronic Quality Management Systems (eQMS) and supporting digital platforms within a GMP pharmaceutical manufacturing facility. This includes systems such as MasterControl, electronic batch records (EBR), Laboratory Information Management Systems (LIMS), Netsuite, and Regulatory Asset Management tools. The role ensures that these systems support compliance, efficiency, and continuous improvement across quality operations.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Serve as the business owner for digital quality systems such as eQMS, LIMS, eRAM, and electronic batch records.
• Lead cross-functional teams in the implementation and optimization of eQMS platforms including MasterControl, EBR, LIMS, Netsuite, and Regulatory Asset Management tools.
• Develop and maintain system governance, validation documentation, and change control procedures in alignment with GMP, 21 CFR Part 11, and EU Annex 1 requirements.
• Serve as the primary liaison between Quality, IT, Manufacturing, Facilities, Supply Chain, and Regulatory Affairs for digital system initiatives.
• Oversee vendor relationships, system upgrades, and integration projects.
• Ensure systems are configured to support CAPA, deviations, complaints, audits, training, and document control processes.
• Monitor system performance and user adoption, providing training and support as needed.
• Drive continuous improvement through data analytics, automation, and digital innovation.
• Maintain compliance with global regulatory requirements and internal quality standards.
• Support internal and external audits related to digital quality systems.

EDUCATION AND/OR EXPERIENCE

Bachelor’s degree in Life Sciences, Engineering, Information Systems, or related field; 5 or more years related experience and/or training; or equivalent combination of education and experience.

• Serve as the business owner for digital quality systems such as eQMS, LIMS, eRAM, and electronic batch records.
• Lead cross-functional teams in the implementation and optimization of eQMS platforms including MasterControl, EBR, LIMS, Netsuite, and Regulatory Asset Management tools.
• Develop and maintain system governance, validation documentation, and change control procedures in alignment with GMP, 21 CFR Part 11, and EU Annex 1 requirements.
• Serve as the primary liaison between Quality, IT, Manufacturing, Facilities, Supply Chain, and Regulatory Affairs for digital system initiatives.
• Oversee vendor relationships, system upgrades, and integration projects.
• Ensure systems are configured to support CAPA, deviations, complaints, audits, training, and document control processes.
• Monitor system performance and user adoption, providing training and support as needed.
• Drive continuous improvement through data analytics, automation, and digital innovation.
• Maintain compliance with global regulatory requirements and internal quality standards.
• Support internal and external audits related to digital quality systems