Supervisor, Quality Systems & Document Control

August Bioservices; Nashville (TN); On-site; USD 110,000 - 155,000; Full time

Job summary

August Bioservices seeks a Supervisor, Quality Systems & Document Control to lead the eQMS (MasterControl) and related GxP systems, owning change control and document governance across the site. This role drives quality system metrics and inspection readiness while supervising the Document Control Specialist to ensure compliant documentation.

You will mentor stakeholders, optimize workflows, oversee data integrity and governance, and partner with QA and regulatory teams to sustain GMP alignment

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 configuring workflows and document routing within MasterControl or similar eQMS platforms.
• Experience leading eQMS validation efforts or system-wide configuration decisions.
• Knowledge of data integrity, GxP compliance, and good documentation practices.
• Experience collaborating with cross-functional teams and understanding regulatory requirements.
• Strong understanding of cgMP, FDA/EMA/ICH regulatory requirements and data integrity principles.

Responsibilities

• Direct and continuously improve the eQMS, quality systems, and document control functions.
• Own MasterControl system strategy and optimization of workflows, forms, and user experience.
• Governance of electronic data, audit trails, access controls, and data integrity.
• Oversee user lifecycle management across GxP systems and license allocation.
• Escalation point for system issues and liaison with MasterControl support.
• Establish KPIs and data analytics to enable informed decision-making.
• Lead Change Review Board meetings and drive cross-functional alignment.
• Author and maintain SOPs and controlled documents related to eQMS processes.
• Mentor staff and support audits/inspections as logistics lead.

Skills

Quality systems management

Regulatory compliance

Leadership

Change control

Data analysis

Project management

SOP development

Cross-functional collaboration

Education

Bachelor’s degree in science/related discipline

Tools

MasterControl

eQMS

Job description

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

Responsibilities

Direct and continuously improve the eQMS, quality systems, and document control functions of Quality Assurance, including the following:

eQMS Administration & Optimization (MasterControl)

• Serve assystemowner forMasterControl, with full accountability for configuration, performance, compliance, and continuous improvement.
• Own and executesystem 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 acrossGxPsystems (eQMS, IMS, asset management).
• Act as the primary escalation point for system-related issues and interface withMasterControltechnical 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, andtimelyexecution.
• 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 andmonitorquality 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, andmaintainSOPs, work instructions, and other controlled documents related toeQMSprocesses, 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 qualitysystemsstaff.
• 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.

Qualifications

• 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 withinMasterControlSoftware or similareQMSplatforms.
• Experience leadingeQMSvalidation efforts or system-wide configuration decisions withinMasterControlor similar platforms.
• Knowledge of data integrity expectations,GxPcompliance, 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