EBR Program Manager - GMP Data Integrity Lead

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

Job summary

Tolmar seeks a Manager, Electronic Batch Records (EBR) for a hybrid role in Windsor, CO. You will lead the EBR team, govern governance, ensure cGMP compliance, and partner with Manufacturing, QA, Validation, IT, and Regulatory Affairs to support compliant batch execution.

Responsibilities include establishing strategy, roadmap, resource planning, and lifecycle management of electronic batch records across manufacturing, launches, tech transfers, and process improvements.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Information Systems, Pharmaceutical Sciences, Biotechnology, Manufacturing Technology, Life Sciences, or related field.
• Minimum ten years in GMP/manufacturing environments with validation, MS&T, or manufacturing systems exposure.
• Experience supervising technical professionals and cross-functional programs.

Responsibilities

• Lead, develop, and set performance expectations for the EBR team within a regulated environment.
• Establish EBR strategy, operating model, priorities, and resource plan aligned with manufacturing goals.
• Oversee design, development, validation, release, and maintenance of EBRs for manufacturing, launches, tech transfers, and process improvements.
• Own governance for EBR templates, change control, access, and deployment; ensure regulatory compliance and data integrity.

Skills

Leadership

GxP systems knowledge

cGMP & Part 11

Regulatory compliance

Vendor management

Strategy & roadmap

Education

Bachelor’s degree in Engineering/Science

Tools

MasterControl

MES

ERP

QMS

LIMS

Job description

Tolmar seeks a Manager, Electronic Batch Records (EBR) for a hybrid role in Windsor, CO. You will lead the EBR team, govern governance, ensure cGMP compliance, and partner with Manufacturing, QA, Validation, IT, and Regulatory Affairs to support compliant batch execution.

Responsibilities include establishing strategy, roadmap, resource planning, and lifecycle management of electronic batch records across manufacturing, launches, tech transfers, and process improvements.