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Supervisor, Quality Systems & Document Control

August Bioservices
United Statesfull_timeVerifiedPosted 7 Aug 2026

About the role

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. 

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