Manager Electronic Batch Record; EBR; Hybrid

Manager Electronic Batch Record (E ) - Hybrid

Job Category: Analytical Chemistry

Requisition Number: MANAG
005906

• Posted :
  August 26, 2026
• Full-Time
• Hybrid

Showing 1 location

Windsor CO
Windsor, CO 80550, USA

Purpose and Scope

The Manager, Electronic Batch Records (E ), provides people, business, and technical leadership for Tolmar’s E  platform and team. This role establishes priorities, develops staff, allocates resources, and oversees system administration, configuration, validation, lifecycle management, and continuous improvement in support of GMP manufacturing. The manager partners with Manufacturing, MS&T, Quality, Validation, IT, Engineering, Supply Chain, and Regulatory Affairs to ensure E  workflows, master batch records, electronic forms, user access, electronic signatures, audit trails, and system changes support compliant batch execution, data integrity, FDA 21 CFR Part 11 requirements, inspection readiness, and Tolmar’s digital manufacturing strategy.

• Manage and develop the E  team; set performance expectations, assign work, provide feedback, support succession planning, and build technical and compliance capabilities.
• Establish the E  strategy, operating model, priorities, resource plan, and roadmap in alignment with manufacturing objectives and Tolmar’s digital manufacturing strategy.
• Oversee the design, development, testing, release, and maintenance of electronic batch records for commercial manufacturing, product launches, technology transfers, validation, engineering, and process improvement activities.
• Own E  governance, including template standards, revision control, change control, release readiness, access management, defect resolution, upgrades, patches, and controlled deployment.
• Provide managerial oversight for CSA/CSV activities, including requirements, specifications, risk assessments, test scripts, qualification protocols, traceability, validation reports, UAT, regression testing, and go-live readiness.
• Ensure effective batch execution support and escalation management; direct troubleshooting, investigations, defect resolution, and corrective actions in partnership with Quality, Validation, technical, and operations teams.
• Ensure team and system compliance with cGMP, FDA 21 CFR Part 11, ALCOA+ data integrity principles, electronic record and signature controls, audit trail practices, EU Annex 11 as applicable, and internal procedures.
• Sponsor workflow optimization, manual process reduction, right-first-time performance, review-by-exception capabilities, and continuous improvement initiatives; define and monitor performance measures.
• Provide direction and governance for integrations between E , MES, ERP, LIMS, historian, automation, document management, and other manufacturing or quality systems.
• Ensure the development and maintenance of process maps, requirements, procedures, work instructions, training materials, standard work, and best practices that support compliant E  operations and user adoption.
• Oversee user and administrator training and ensure timely support for deviations, CAPAs, change controls, periodic reviews, audits, inspections, KPI reporting, and E
  -related projects.
• Manage budgets, vendors, contracts, licenses, and resource capacity for the E  function.
• Manage employee performance and development, including setting clear expectations, providing ongoing coaching and feedback, completing performance evaluations, addressing performance concerns, and establishing individual development plans.
• Perform other duties as assigned.

Knowledge, Skills & Abilities

• Demonstrated ability to lead, coach, and develop technical professionals, establish priorities, manage performance, and foster accountability in a regulated environment.
• Strong knowledge of pharmaceutical manufacturing, batch record management, cGMP documentation, electronic manufacturing records, data integrity expectations, FDA 21 CFR Part 11, EU Annex 11 as applicable, ALCOA+, CSA/CSV, and risk-based validation.
• Experience leading E , MES, quality systems, manufacturing applications, or comparable validated GxP systems, including governance, configuration, workflow design, troubleshooting, and…