Senior Manager, eQMS Administration & Training

Reports to:

Sr. Director, Quality Assurance

The Senior Manager, eQMS Administration & Training serves as the system owner for the company’s Master Control 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 Master Control is inspection‑ready, scalable, and aligned with GxP and ICH expectations.

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

• Own the end‑to‑end document lifecycle within Master Control 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.

• Own Master Control 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
• Lead the implementation and validation support for Master Control 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.

• Ensure Master Control is continuously inspection‑ready by:
• 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.
• Participate in system change control, configuration updates, and periodic review activities.
• Coordinate with Master Control as the vendor for releases and enhancements, issue resolution and validation package updates
• Identify and implement continuous improvement opportunities using Master Control capabilities and industry best practices.
• Provide internal user support and ongoing system training for the organization.

• Bachelor’s degree in Life Sciences, IT, or related discipline.
• 5+ years experience administering Master Control 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.
• Strong communication skills and ability to partner across functions.

• 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 Master Control validation documentation and risk‑based validation concepts.

Sironax is an equal opportunity employer committed to diversity, equity, and inclusion. We welcome applicants from all backgrounds and are dedicated to creating a work environment where everyone feels valued and empowered.