Quality Systems & Document Control Leader

August Bioservices; Nashville (TN); On-site; USD 90,000 - 120,000; Full time

Job summary

August Bioservices seeks a Supervisor for Quality Systems & Document Control to lead the eQMS and document control at the site. The role owns MasterControl configurations, governance, and data integrity within GMP environments, driving optimization and readiness for inspections.

You will supervise the Document Control Specialist, oversee change control, and coordinate cross-functional quality improvements to ensure compliant documentation and robust regulatory readiness.

Qualifications

• Bachelor’s degree in science, business management, or information management.
• 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 or similar QMS platforms.
• Experience leading eQMS validation efforts or system-wide configuration decisions within MasterControl or similar platforms.
• Knowledge of data integrity, GxP, and good documentation practices.
• Strong project management and organizational skills.
• Excellent analytical skills with the ability to translate data into actionable insights.
• Ability to mentor and influence cross-functional teams.

Responsibilities

• Own 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.
• Lead Change Review Board meetings and drive cross-functional alignment.
• Mentor stakeholders on proposed changes, impact assessments, and regulatory considerations.
• Provide audits support and coordinate with SMEs for audit responses.
• Directly supervise the Document Control Specialist.

Skills

Quality systems management

GxP compliance

MasterControl

Change control

Data integrity

Project management

Regulatory knowledge

Education

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

Tools

MasterControl

Job description

August Bioservices seeks a Supervisor for Quality Systems & Document Control to lead the eQMS and document control at the site. The role owns MasterControl configurations, governance, and data integrity within GMP environments, driving optimization and readiness for inspections.

You will supervise the Document Control Specialist, oversee change control, and coordinate cross-functional quality improvements to ensure compliant documentation and robust regulatory readiness.