Supervisor, Quality Systems & Document Control

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

The Supervisor, Quality Systems & Document Controlis responsible forthe administration, governance, and continuous improvement of August Bioservices' electronic quality management system (eQMS) and associated GxPsystems, with primary ownership of MasterControl. This role owns the site-wide change control program, drives quality system metrics and inspectionreadiness, and provides direct supervision to the Document Control Specialist to ensure consistent, compliant documentation practices across the organization.

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 GxPsystems (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, inspectionreadiness, 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.

• Bachelor’s degree ina 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