Remote Manager, GxP Manufacturing Applications

Danaher Corporation; United States; Teletrabalho; USD 95 000 - 140 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Bonus potential

Remote work

Resumo da oferta

Integrated DNA Technologies (IDT), a Danaher operating company, seeks a Manager of Manufacturing Applications to lead GxP-regulated manufacturing IT platforms from a fully USA remote location. You will drive lifecycle management, validation, and cross-functional collaboration with Quality and Manufacturing teams.

The role requires 4+ years in regulated manufacturing IT, strong IT governance, and hands-on coding in C#, JavaScript/TypeScript with API integrations, plus leadership experience.

Qualificações

• Bachelor’s degree in Information Technology, Engineering, Life Sciences, or a related discipline.
• At least 4 years of experience supporting or managing manufacturing IT systems in regulated environments.
• Experience with supervisors, team lead, or management roles (1+ year).
• Strong understanding of manufacturing systems (MES, LIMS, QMS, etc.).
• Experience with IT service management and quality governance processes; hands-on development with C#, JavaScript/TypeScript, React, APIs.

Responsabilidades

• Own end-to-end management of GxP-regulated manufacturing systems, including lifecycle planning, upgrades, and decommissioning.
• Ensure systems operate in compliance with GxP regulations and quality standards.
• Coordinate validation planning, risk assessments, testing, and documentation with Validation team.
• Translate operational needs into compliant system capabilities with Quality and Manufacturing stakeholders.
• Oversee system performance, incident management, CAPAs, and continuous improvement.
• Manage vendors and service partners ensuring compliance and performance.
• Maintain inspection-ready documentation and support audits and regulatory inspections.

Conhecimentos

Manufacturing IT

GxP systems

Team lead

API integrations

C#

JavaScript/TypeScript

React

Formação académica

Bachelor’s degree in IT/Engineering/Life Sciences

Ferramentas

MES

LIMS

QMS

Descrição da oferta de emprego

Integrated DNA Technologies (IDT), a Danaher operating company, seeks a Manager of Manufacturing Applications to lead GxP-regulated manufacturing IT platforms from a fully USA remote location. You will drive lifecycle management, validation, and cross-functional collaboration with Quality and Manufacturing teams.

The role requires 4+ years in regulated manufacturing IT, strong IT governance, and hands-on coding in C#, JavaScript/TypeScript with API integrations, plus leadership experience.