MES Program Delivery Lead - Senior Manager
BioSpace · Troy, NY · 3 days ago
Management$108k–$206k/yrFull-time
About the role
Join our IOPS IT team as a MES Program Delivery Lead, driving end-to-end delivery of our Manufacturing Execution System (MES) program across global manufacturing sites. You will lead cross-functional teams, manage budgets, and ensure all MES deliverables meet regulatory standards.
Responsibilities
- Own end-to-end MES program delivery including solution design, build, validation, deployment, and post-go-live stabilization
- Lead and direct cross-functional delivery teams including internal staff, system integrators, and vendors
- Manage release planning, sprint ceremonies, dependencies, and resource allocation
- Partner with business owners and senior stakeholders to define program scope, roadmap, deliverables, and timelines
- Manage budgets, workload balancing, and capacity planning
- Proactively identify, triage, and remove impediments; spot and mitigate risks
- Ensure all MES deliverables meet GxP, ALCOA+, and 21 CFR Part 11 requirements
- Lead and develop direct reports through performance feedback meetings, ensuring training requirements are met and team capabilities continue to grow
Requirements
- Demonstrated experience applying SDLC and CSA methodologies, including risk-based approaches to validation of GxP computerized systems
- Experience delivering MES programs including electronic batch records, recipe management, and integrations with automation/SCADA, ERP, LIMS, and historian systems
- Agile Scrum Master certification (CSM or PSM) preferred
- Strong stakeholder management and communication skills; able to translate complex technical delivery status into clear narratives for executive audiences
- Experience managing system integrators, vendor relationships, and cross-functional delivery teams in a regulated pharmaceutical or biotech environment
Qualifications
- BS/BA in Information Technology or a related field
- 8+ years of experience in delivery leadership, program/project management, or IT management
- 10+ years of experience in delivery leadership, program/project management, or IT management preferred