Work Location: Durham County, North Carolina

Summary:

The QA Systems Manager is responsible for leading the implementation, migration, validation, and ongoing management of electronic Quality Management Systems (eQMS) and pharmaceutical computerized systems. This role ensures compliance with regulatory standards and supports continuous improvement initiatives across multiple sites.

Responsibilities:

• Lead and manage key computerized system projects, ensuring timely delivery and alignment with project plans.
• Oversee the implementation and transition of new tools within the electronic Quality Management System, ensuring compliance and smooth adoption across sites.
• Act as the Subject Matter Expert for eQMS platforms, providing training, troubleshooting, and ongoing support to staff.
• Maintain and manage system lifecycle documentation, including user requirements, risk assessments, validation protocols, data migration plans, and SOPs.
• Promote a culture of change acceptance and continuous improvement in support of quality initiatives.
• Provide regular updates to senior management and stakeholders, reporting on metrics, risks, issues, and progress for all sites involved.
• Support employees working on computerized system projects, including lab equipment validation and related activities.
• Ensure compliance with GMP, regulatory expectations, and industry guidance, maintaining audit readiness and supporting inspections as needed.

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related discipline preferred but not required.
• Training in Computer System Validation within a pharmaceutical GMP environment; minimum 5 years’ experience in the pharmaceutical industry preferred.
• Experience with Quality Management Systems, including deviations, change controls, and CAPAs.
• Proven experience with MasterControl or similar eQMS platforms, including configuration, administration, and user training.
• Strong knowledge of CSV and GxP system implementations in regulated environments.
• Hands-on experience with CSV activities related to Empower CDS, including validation, data migration, system archiving, audit trail management, user access, and data integrity.
• Demonstrated success in leading system migrations or large-scale QMS digitalization projects.
• Experience in writing and maintaining validation documentation in accordance with GMP standards.
• Experience working within a Quality function on computer systems integration projects.

Published Category: Quality & Validation