Supervisor, Quality Systems & Document Control

Job description

The Supervisor, Quality Systems & Document Control is responsible for the administration, governance, and continuous improvement of August Bioservices' electronic quality management system (eQMS) and associated GxP systems, with primary ownership of MasterControl. This role owns the site-wide change control program, drives quality system metrics and inspection readiness, and provides direct supervision to the Document Control Specialist to ensure consistent, compliant documentation practices across the organization. ### Responsibilities **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. ### Qualifications - Bachelor’s degree in a science, business management, or information management related discipline. - 5+ years of progressive experience in quality systems management or in a highly regulated industry. - Experience developing and configuring workflows, forms, and document routing structures within MasterControl Software or similar eQMS platforms. - Experience leading eQMS validation efforts or system-wide configuration decisions within MasterControl or similar platforms. - Knowledge of data integrity expectations, GxP compliance, software development lifecycle, and good documentation practices. - Experience interacting and working with cross-functional teams. - Knowledge of and ability to follow applicable regulatory requirements (GMP, GLP, ISO, etc.). - Strong technical abilities with an understanding of quality management systems. - Strong understanding of governing regulations and standards for computerized quality systems and data integrity. - Deep knowledge of cGMP, FDA, EMA, and ICH regulatory requirements. - Strong understanding of data integrity principles (ALCOA++) - Experience with system Validation and computerized systems compliance - Excellent Analytical skills with the ability to translate data into actionable insights - Strong project management and organizational skills - Effective communication and stakeholder engagement skills