Direct and continuously improve the eQMS, quality systems, and document control functions of Quality Assurance, including the following: 

eQMS Administration & Optimization (MasterControl) 

• Serve as system owner for MasterControl, with full accountability for configuration, performance, compliance, and continuous improvement. 

• Own and execute system strategy, including optimization of quality event workflows, vaults, lifecycles, InfoCards, and electronic forms to enhance efficiency and user experience. 

• Ensure robust governance of electronic data, including audit trail oversight, access controls, and data integrity standards. 

• Oversee user lifecycle management (onboarding, offboarding, role changes), license allocation, and access governance across GxP systems (eQMS, IMS, asset management). 

• Act as the primary escalation point for system-related issues and interface with MasterControl technical support. 

• Establish advanced reporting and analytics capabilities to enable data-driven decision-making across the organization. 

Quality Systems & Change Control 

• Own and continuously improve the site-wide change control program, ensuring risk-based, compliant, and timely execution. 

• Facilitate Change Review Board (CRB) meetings and drive cross-functional alignment. 

• Mentor and coach stakeholders in the development of high-quality change controls, providing guidance on proposed changes, impact assessments, and regulatory considerations to ensure changes are appropriately justified, compliant with GMP expectations, and aligned with QMS requirements. 

• Establish and monitor quality system KPIs and performance metrics to ensure compliance with GMP and internal standards. 

• Develop robust data collection and trending methodologies to support routine and ad hoc reporting. 

• Analyze trends and provide actionable recommendations to improve quality system effectiveness, inspection readiness, and operational performance. 

• Lead or support cross-functional quality improvement initiatives to enhance QMS maturity and efficiency. 

• Author, review, and maintain SOPs, work instructions, and other controlled documents related to eQMS processes, ensuring clarity, compliance, and consistency. 

Supervisory Responsibilities 

• Directly supervise the Document Control Specialist, including workload assignment, performance management, training, and professional development. 

• Serve as a point of escalation and mentor for document control and quality systems staff. 

• Provide support during audits and regulatory inspections by serving as logistics room lead. Under time-sensitive conditions, manage and provide documents requested by the auditor/inspector and coordinate with the appropriate SMEs to answer questions posed by the auditor/inspector.