Manager of Manufacturing Applications - Onsite
Core
Manage compliant, reliable, and validated enterprise manufacturing platforms supporting 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 / GxP Manufacturing
Deliverable
production ML models | product features | infrastructure
Required skills
GxP compliance and validation lifecycle management, IT service management (ITSM), change control and risk assessment, vendor management, root cause analysis, C#, JavaScript/TypeScript, React, API integrations
Preferred skills
Global/multi-site manufacturing experience, manufacturing digital transformation, advanced GxP system validation and compliance oversight
Technologies
C#, JavaScript/TypeScript, React, MES, LIMS, QMS
Responsibilities
Own end-to-end lifecycle management of GxP manufacturing systems; Ensure compliance with GxP regulations and inspection readiness; Coordinate validation planning, testing, and change impact analysis; Partner with Quality and Manufacturing to translate operational needs into system capabilities; Oversee operational stability, incident management, and CAPAs; Manage vendors and service partners for GxP systems; Maintain inspection-ready documentation and support audits.
Seniority
Manager, hands-on technical leadership