Purpose and ScopeThe Manager, Electronic Batch Records (EBR), provides people, business, and technical leadership for Tolmar's EBR 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 EBR 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.
Essential Duties & Responsibilities- Manage and develop the EBR team; set performance expectations, assign work, provide feedback, support succession planning, and build technical and compliance capabilities.
- Establish the EBR 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 EBR 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 EBR, 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 EBR 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 EBR-related projects.
- Manage budgets, vendors, contracts, licenses, and resource capacity for the EBR 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 EBR, MES, quality systems, manufacturing applications, or comparable validated GxP systems, including governance, configuration, workflow design, troubleshooting, and lifecycle support.
- Ability to translate business, manufacturing, quality, validation, and regulatory requirements into a clear strategy, executable priorities, compliant EBR solutions, and measurable outcomes.
- Knowledge of system integrations across EBR, MES, ERP, LIMS, historian, automation, document management, and other enterprise applications; vendor and budget management experience preferred.
- Strong leadership, decision-making, analytical, communication, change management, project portfolio management, and cross-functional influence skills.
Education & Experience- Bachelor's degree in Engineering, Computer Science, Information Systems, Pharmaceutical Sciences, Biotechnology, Manufacturing Technology, Life Sciences, or a related scientific or technical discipline required; equivalent directly related experience may be considered. MBA degree preferred.
- Minimum of ten years of progressive experience in pharmaceutical manufacturing, manufacturing systems, automation, validation, MS&T, engineering, quality, or another GMP-regulated environment required.
- Minimum of six years supporting EBR, MES, manufacturing applications, quality systems, or validated GxP computerized systems required.
- Prior experience supervising, leading, or developing technical professionals and managing cross-functional programs or projects required.
- Experience with EBR implementation, administration, validation, change control, deviations/CAPAs, training, digital transformation, regulatory inspections, and platforms such as MasterControl, MES, ERP, QMS, or LIMS preferred; relevant certifications are a plus.
Working Conditions- Normal office and GMP manufacturing conditions with frequent interaction with direct reports, production teams, senior leaders, vendors, and cross-functional stakeholders.
- Occasional travel may be required.
Compensation and Benefits- Annual pay range $150,000 to $170,000 depending on experience
- Bonus Eligible
- Benefits information: https://www.tolmar.com/careers/employee-benefits
Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.
