Business Change Manager

Emploi pas sur LinkedIn

🕒 il y a 14 jours

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

👻 Score fantôme 17%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of GMP Pros, Inc.®

GMP Pros, Inc.®

11 - 50 employés

Fondée en 2013

💼 Conseil

🍽️ Alimentation et boissons

🏭 Fabrication

Consulting • Food & Beverage • Manufacturing

GMP Pros est un acteur du changement en pleine croissance pour les industries pharmaceutiques et de la santé animale, avec une mission unique : rendre les gens plus heureux. À première vue, nous sommes une entreprise d'ingénierie offrant des services de conception de processus, d'excellence opérationnelle, de solutions techniques et une véritable science des données tournée vers l'avenir. Cependant, ces capacités ne sont que des outils utilisés pour générer de réels résultats économiques, augmentant les bénéfices et, en fin de compte, satisfaisant les personnes bénéficiant de la simplicité conçue. Notre siège est situé à Omaha, NE, et notre main-d'œuvre diversifiée produit des résultats à l'échelle nationale et mondiale avec bon nombre des plus grandes entreprises pharmaceutiques mondiales.

Description

• Manage the human side of the implementation • Drive adoption planning • Run stakeholder alignment sessions • Own the end-user training program, including classroom, remote, and hands-on floor practice • Manage communications around PI design decisions and go-live readiness • Build trust among GSK process owners, QA team, and operations personnel before PPQ • Develop training materials from system design documentation, SOPs, and batch records • Develop adoption plans, readiness assessments, and go/no-go criteria for regulated system deployments • Support process owners and QA during show-and-tell design review sessions

🎯 Exigences

• 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 formal classroom instruction, remote/virtual sessions, and hands-on floor practice with operators and technical staff • Strong stakeholder facilitation skills across 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 related approval workflows, communication protocols, and change control expectations • Experience developing adoption plans, readiness assessments, and go/no-go criteria for system deployments in regulated environments • Prosci ADKAR or equivalent formal change management certification preferred • Prior experience on an eBR/MES implementation at a large pharma or biotech facility preferred • Experience working within a multi-vendor project structure with a prime contractor preferred • Familiarity with Veeva Vault or a comparable QMS for managing procedure and training documentation preferred • Experience supporting process owners and QA during show-and-tell design review sessions preferred • Familiarity with Veeva VQD, Microsoft Teams/SharePoint, Kneat, and eLearning or training authoring tools

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