Quality Systems & eQMS Lead (MasterControl)

August Bioservices; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

August Bioservices is seeking a Supervisor, Quality Systems & Document Control to own and optimize the eQMS and related GxP systems, with primary responsibility for MasterControl. You will govern change control, drive quality system metrics, and mentor the Document Control Specialist to ensure compliant documentation practices.

You will lead system improvements, supervise documentation workflows, and ensure data integrity across QA processes.

Qualifications

• Bachelor’s degree in a science, business management, or information management discipline.
• 5+ years of progressive experience in quality systems management or in a highly regulated industry.
• Experience developing workflows, forms, and document routing in MasterControl or similar QMS platforms.
• Experience leading eQMS validation efforts and system-wide configuration decisions in MasterControl or similar platforms.
• Knowledge of data integrity expectations (ALCOA++), GxP compliance, and regulatory requirements.

Responsibilities

• Direct and continuously improve the eQMS, quality systems, and document control functions across QA.
• Serve as system owner for MasterControl with accountability for configuration and performance.
• Own and optimize system strategy, including workflows, data vaults, lifecycles, and electronic forms.
• Oversee governance of electronic data, audit trails, access controls, and data integrity standards.
• Lead Change Review Board meetings and drive cross-functional alignment on changes.
• Mentor stakeholders in developing compliant change controls and regulatory considerations.
• Establish KPIs and metrics to ensure GMP compliance and QMS effectiveness.
• Author, review, and maintain SOPs and controlled documents for eQMS processes.

Skills

MasterControl

eQMS administration

Change control

GxP compliance

Data integrity

Audits & inspections

Cross-functional collaboration

Project management

Education

Bachelor’s degree in science, business management, or information management

Tools

MasterControl

Quality Management System

Job description

August Bioservices is seeking a Supervisor, Quality Systems & Document Control to own and optimize the eQMS and related GxP systems, with primary responsibility for MasterControl. You will govern change control, drive quality system metrics, and mentor the Document Control Specialist to ensure compliant documentation practices.

You will lead system improvements, supervise documentation workflows, and ensure data integrity across QA processes.