The BCM manages the human side of this implementation. GSK's process owners, QA team, and operations personnel need to trust the system before PPQ. The BCM drives adoption planning, runs stakeholder alignment sessions, owns the end-user training program (classroom, remote, and hands-on floor practice), and manages communication around PI design decisions and go-live readiness. In a pharmaceutical MES context, this role requires someone who understands both the change management discipline and the regulatory environment — training without validation traceability, or stakeholder alignment without an understanding of GMP impact, is not enough.
Required Qualifications
- 5+ years of change management or adoption experience on enterprise technology implementations in FDA-regulated manufacturing
- Experience delivering end-user training programs for MES, eBR, or LIMS systems — including development of training materials from system design documentation, SOPs, and batch records
- Ability to develop and deliver training across multiple modalities: formal classroom instruction, remote/virtual sessions, and hands-on floor practice with operators and technical staff
- Strong stakeholder facilitation skills across mixed audiences — process owners, QA professionals, manufacturing operators, and IT/systems stakeholders
- Understanding of how change management intersects with CSV/CQV requirements — particularly around SOP updates, work instruction changes, and training documentation for regulated systems
- Familiarity with GMP manufacturing environments and the approval workflows, communication protocols, and change control expectations that govern them
- Experience developing adoption plans, readiness assessments, and go/no-go criteria for system deployments in regulated environments
Preferred Qualifications
- Prosci ADKAR or equivalent formal change management certification
- Prior experience on an eBR/MES implementation at a large pharma or biotech facility
- Experience working within a multi-vendor project structure with a prime contractor
- Familiarity with Veeva Vault or a comparable QMS for managing procedure and training documentation
- Experience supporting process owners and QA during show-and-tell design review sessions
Key Tools & Platforms
Veeva VQD (training/SOP documentation) | Microsoft Teams / SharePoint | Kneat (awareness) | eLearning or training authoring tools (preferred)
