Business Change Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the human aspects of the implementation process.

• Lead the planning for user adoption.

• Facilitate sessions to align stakeholders.

• Take ownership of the end-user training program, which includes classroom instruction, remote learning, and practical hands-on experience on the floor.

• Manage communications regarding PI design decisions and readiness for go-live.

• Establish trust with GSK process owners, the QA team, and operational staff prior to PPQ.

• Create training materials based on system design documentation, standard operating procedures (SOPs), and batch records.

• Formulate adoption plans, readiness assessments, and go/no-go criteria for deploying regulated systems.

• Assist process owners and QA personnel during design review sessions that showcase design features.

⛳️ Requirements

• Minimum of 5 years of experience in change management or user adoption for enterprise technology implementations in FDA-regulated manufacturing.

• Proven experience in delivering end-user training programs for MES, eBR, or LIMS systems, including the creation of training materials derived from system design documentation, SOPs, and batch records.

• Capable of developing and delivering training through formal classroom settings, remote or virtual sessions, and hands-on practice with both operators and technical staff.

• Strong skills in facilitating stakeholder engagement among process owners, QA professionals, manufacturing operators, and IT/systems stakeholders.

• Knowledge of the intersection between change management and CSV/CQV requirements, especially regarding updates to SOPs, modifications to work instructions, and training documentation for regulated systems.

• Familiarity with GMP manufacturing environments, including relevant approval workflows, communication protocols, and expectations for change control.

• Experience in creating adoption plans, readiness assessments, and go/no-go criteria for system deployments within regulated environments.

• Preferred: Prosci ADKAR or an equivalent formal change management certification.

• Preferred: Previous experience with an eBR/MES implementation at a large pharmaceutical or biotech facility.

• Preferred: Experience operating within a multi-vendor project framework alongside a prime contractor.

• Preferred: Familiarity with Veeva Vault or a similar Quality Management System (QMS) for managing procedural and training documentation.

• Preferred: Experience aiding process owners and QA during design review sessions that demonstrate design features.

• Preferred: Familiarity with tools such as Veeva VQD, Microsoft Teams/SharePoint, Kneat, and eLearning or training authoring software.

🏝️ Benefits

• Opportunity to work with a dynamic team in a leading industry.

• Comprehensive benefits package including health insurance, retirement plans, and professional development opportunities.

• Supportive work environment fostering growth and innovation.