Senior Manager, Electronic Batch Records (EBR)

Tolmar-7; Windsor (CO); Hybrid; USD 150,000 - 170,000; Full time

Job summary

Tolmar is seeking a Manager of Electronic Batch Records (EBR) to lead the EBR platform in a hybrid setting at Windsor, CO. You will direct staff, align the EBR strategy with manufacturing goals, and ensure compliant batch execution with robust governance and lifecycle management.

You will oversee governance for EBR and related systems, drive continuous improvement, and collaborate with QA, Validation, IT, and Operations to ensure data integrity and regulatory readiness.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Information Systems, Pharmaceutical Sciences, Biotechnology, Manufacturing Technology, Life Sciences, or a related scientific or technical discipline.
• Minimum of ten years of progressive experience in pharmaceutical manufacturing, manufacturing systems, automation, validation, MS&T, engineering, quality, or another GMP-regulated environment.
• Minimum of six years supporting EBR, MES, manufacturing applications, quality systems, or validated GxP computerized systems.

Responsibilities

• Lead and develop the EBR team; set performance expectations, assign work, provide feedback, support succession planning, and build capabilities.
• Oversee the design, development, testing, release, and maintenance of electronic batch records for commercial manufacturing, product launches, validation, and transfers.
• Sponsor workflow optimization and continuous improvement initiatives; define and monitor performance measures.
• Ensure team and system compliance with cGMP, FDA 21 CFR Part 11, ALCOA+ data integrity principles, and related regulations.

Skills

Leadership

Regulatory compliance

Data integrity

Cross-functional collaboration

GxP governance

Change management

Education

Bachelor’s degree (Engineering/Science)

MBA (preferred)

Tools

MasterControl

MES

ERP

QMS

LIMS

Job description

Tolmar is seeking a Manager of Electronic Batch Records (EBR) to lead the EBR platform in a hybrid setting at Windsor, CO. You will direct staff, align the EBR strategy with manufacturing goals, and ensure compliant batch execution with robust governance and lifecycle management.

You will oversee governance for EBR and related systems, drive continuous improvement, and collaborate with QA, Validation, IT, and Operations to ensure data integrity and regulatory readiness.