Quality Systems & eQMS Lead — Change Control Champion

Augustbioservices; Nashville (TN); On-site; USD 110,000 - 145,000; Full time

Job summary

August Bioservices seeks a Supervisor of Quality Systems & Document Control to own MasterControl and drive the eQMS, change control, and documentation governance across the site. You will lead governance, data integrity, and cross-functional collaboration to ensure regulatory readiness.

Responsibilities include optimizing eQMS workflows, supporting audits, mentoring staff, and delivering KPIs aligned with GMP requirements and ICH guidelines.

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 EQA 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

Responsibilities

• Serve as system owner for MasterControl, with full accountability for configuration, performance, compliance, and continuous improvement.
• Own and execute system strategy, including optimization of workflows, lifecycles, and forms to enhance efficiency.
• Ensure governance of electronic data, including audit trails, access controls, and data integrity.
• Oversee user lifecycle management, license allocation, and access governance across GxP systems.
• Lead Change Review Board (CRB) meetings and drive cross-functional alignment on changes.
• Mentor stakeholders in development of high-quality change controls and regulatory considerations.
• Establish quality system KPIs and performance metrics to ensure GMP compliance.
• Develop data collection and trending methodologies for routine reporting.
• Lead audits/inspections support by coordinating with SMEs and preparing documentation.

Skills

Quality systems management

eQMS (MasterControl)

Change control

GxP compliance

Regulatory knowledge

Data integrity ALCOA++

Leadership / mentoring

Cross-functional collaboration

Analytical skills

Project management

Education

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

Tools

MasterControl

Job description

August Bioservices seeks a Supervisor of Quality Systems & Document Control to own MasterControl and drive the eQMS, change control, and documentation governance across the site. You will lead governance, data integrity, and cross-functional collaboration to ensure regulatory readiness.

Responsibilities include optimizing eQMS workflows, supporting audits, mentoring staff, and delivering KPIs aligned with GMP requirements and ICH guidelines.