Senior Manager, eQMS Administration & Training

The Senior Manager, eQMS Administration & Training serves as the system owner for the company’s MasterControl Quality Management System, supporting a growing, global clinical-stage organization. This role is responsible for configuration, governance, and operation of the eQMS platform. The role partners closely with Quality, Clinical Operations, Regulatory and IT to ensure MasterControl is inspection-ready, scalable, and aligned with GxP and ICH expectations.

I. MasterControl System Ownership & Administration

• Serve as the primary MasterControl system owner and administrator across all enabled modules.
• Administer, configure, and maintain:
  • Vault structure and governance
  • Document types, forms, metadata, numbering schemes, and lifecycles
  • Approval and change workflows aligned with SOPs
  • User roles, permissions, and access groups
• Manage MasterControl forms, routes and workflow configurations to ensure controlled, compliant document and training processes.
• Maintain system configuration documentation

II.Document Control (Current-State Ownership)

• • Own the end-to-end document lifecycle within MasterControl Documents
    • Ensure document workflows and vault usage support global GxP compliance, clear ownership and traceability, inspection-ready audit trails
  • Partner with Quality SMEs to continuously improve document governance and usability.

• Monitor and periodically report on KPIs.

III.Training Administration & Compliance

• Own MasterControl Training as both the system administrator and process owner for training management
• Design and maintain role-based curricula, training assignment rules and retraining triggers, job-function and SOP-based training matrices
• Monitor and periodically report on KPIs
• Drive training completion with groups and individuals as needed
• Support onboarding, role changes, and offboarding

IV.Supplier & Audit Module Implementation

• Lead the implementation and validation support for MasterControl Supplier and Audit modules
  • Translate business and quality requirements into supplier qualification workflows
  • Audit planning, execution, findings and CAPA linkage
• Partner with Quality Assurance and Procurement to align supplier and audit processes to system design.
• Support module rollout, user training and change management.

V.Inspection Readiness & Compliance Support

• Ensure MasterControl is continuously inspection-ready by:
  • Maintaining clean audit trails
  • Supporting rapid, accurate data retrieval
  • Producing inspection-ready reports (documents, training, supplier status)
• Serve as a point of contact during audits and inspections for system demonstrations and record retrieval.
• Ensure system use aligns with ICH GCP, ICH E6(R3), and data integrity expectations.

VI.Governance, Change Control & Continuous Improvement

• Participate in system change control, configuration updates, and periodic review activities.
• Coordinate with MasterControl as the vendor for releases and enhancements, issue resolution and validation package updates
• Identify and implement continuous improvement opportunities using MasterControl capabilities and industry best practices.
• Provide internal user support and ongoing system training for the organization.

Required

• Bachelor’s degree in Life Sciences, IT, or related discipline.
• 5+ years experience administering MasterControl or a comparable validated eQMS in a GxP-regulated environment.
• Experience leading or significantly supporting implementation of additional eQMS modules (Supplier, Audit, Events/CAPA, etc.).
• Strong understanding of GxP regulations and inspection readiness.
• Experience supporting multi-program, multi-site organizations.
• Strong communication skills and ability to partner across functions.

Preferred

• Experience in a clinical-stage pharmaceutical or biotech company.
• Familiarity with sponsor responsibilities under ICH E6(R3).
• Experience supporting training compliance as a governed business process.
• Experience with MasterControl validation documentation and risk-based validation concepts.