Manager of Manufacturing Applications - Onsite
Core
Managing compliant, reliable, and validated enterprise manufacturing platforms for GxP-regulated operations in life sciences and diagnostics.
Role type
Manager of Manufacturing Applications (GxP)
Builds
GxP-compliant manufacturing systems, integrations, and automation platforms for life sciences research and diagnostics.
Domain
Life Sciences / Diagnostics / Biotechnology / Regulated Manufacturing
Deliverable
production ML models | product features | infrastructure
Required skills
GxP compliance management, lifecycle planning for manufacturing systems, validation planning and risk assessment, change control governance, incident management and root cause analysis, vendor management for GxP systems, stakeholder partnership with Quality and Manufacturing, hands-on software development (C#, JavaScript/TypeScript, React, APIs), manufacturing system knowledge (MES, LIMS, QMS).
Preferred skills
Global or multi-site manufacturing environment experience, manufacturing digital transformation initiatives, ERP-manufacturing system integrations in regulated contexts.
Responsibilities
Own end-to-end management of GxP-regulated manufacturing systems including lifecycle planning and decommissioning; Ensure manufacturing systems operate in compliance with GxP regulations and inspection readiness; Coordinate with Validation team to govern change management, testing, and documentation; Partner with Quality and Manufacturing to translate operational needs into compliant capabilities; Oversee operational stability, incident management, and CAPAs; Manage vendors supporting GxP systems; Maintain inspection-ready documentation and support audits.
Seniority
Manager, hands-on IC with strategic oversight