Senior QMS & eQMS Lead - MasterControl & Change Control

August Bioservices; Tennessee; On-site; USD 90,000 - 130,000; Full time

Job summary

August Bioservices is seeking a Supervisor, Quality Systems & Document Control to lead the eQMS and related GxP systems. You will own MasterControl, drive site-wide change control, and ensure inspection readiness while supervising the Document Control Specialist for compliant documentation practices.

You will mentor teams, develop robust metrics, and coordinate with internal SMEs to ensure timely, accurate responses during audits and regulatory reviews. Strong regulatory knowledge is essential.

Qualifications

• Bachelor's degree in science, business, or information management.
• 5+ years in quality systems management or regulated industry.
• Experience configuring workflows and forms in MasterControl or similar eQMS.
• Experience leading eQMS validation efforts and system configurations.
• Knowledge of data integrity, GxP, and software development lifecycle.
• Experience with cross-functional teams.
• Familiarity with GMP/GLP and regulatory requirements.
• Strong understanding of data integrity principles (ALCOA++).
• Excellent analytical, project management, and communication skills.
• Ability to mentor cross-functional teams.

Responsibilities

• Direct and continuously improve eQMS and document control across QA.
• Own MasterControl system ownership, configuration, and upgrades.
• Develop reports and analytics for inspection readiness.
• Oversee change control program and CRB meetings.
• Mentor stakeholders on changes, impact assessments, and regulatory considerations.
• Maintain SOPs and controlled documents.
• Supervise Document Control Specialist and mentor staff.
• Support audits and regulatory inspections by coordinating documents.

Skills

Quality systems management

Cross-functional collaboration

Data analysis

Regulatory understanding

Documentation practices

Education

Bachelor's degree in science/related field

Tools

MasterControl

GxP documentation systems

Job description

August Bioservices is seeking a Supervisor, Quality Systems & Document Control to lead the eQMS and related GxP systems. You will own MasterControl, drive site-wide change control, and ensure inspection readiness while supervising the Document Control Specialist for compliant documentation practices.

You will mentor teams, develop robust metrics, and coordinate with internal SMEs to ensure timely, accurate responses during audits and regulatory reviews. Strong regulatory knowledge is essential.