Quality Systems & Document Control Supervisor

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 
• Ability to mentor and influence cross-functional teams