API & IT Systems Lead (GxP Compliance)

BioSpace; West Lebanon (NH); Vor Ort; USD 110.000 - 160.000; Vollzeit

Zusammenfassung

Novo Nordisk in New Hampshire, West Lebanon, seeks an experienced IT systems lead to independently manage API automation and IT systems through their lifecycle, ensuring compliance with GxP, data protection, and company requirements. The role involves validation, maintenance, risk assessment, change control, and incident resolution to support reliable operations.

You will collaborate with IT Security and SMEs to document controls, coordinate validation testing (IQ/OQ/PQ, FAT/SAT/UAT), and

Qualifikationen

• Bachelor's degree in Information Technology or related field; 5+ years of IT systems management experience focusing on compliance (GxP)
• Experience engineering, operating and maintaining IT systems; supporting automation/batch processes is a plus
• Understanding of IT governance frameworks (COBIT, ITIL, GAMP) and 21CFR Part 11/PIC/S Annex 11 is a plus
• Demonstrated ability to manage system lifecycle including validation, operation, maintenance and retirement; strong documentation practices
• Experience in regulatory audits & inspections; ability to plan and deliver system lifecycle work with cross-functional teams

Aufgaben

• Manage lifecycle and validation for assigned IT systems to meet requirements and compliance
• Collaborate with IT Security to document and maintain system security controls
• Coordinate validation/testing (IQ/OQ/PQ, FAT/SAT/UAT) for systems
• Develop lifecycle plans for upgrades and retirement based on risk and operational needs
• Lead risk assessments and change control activities for assigned systems
• Review and approve testing protocols to confirm they meet approved requirements
• Maintain system configurations and documentation baselines
• Coordinate user training and access reviews for assigned systems
• Lead investigations and corrective actions for incidents and deviations
• Ensure compliance with healthcare laws, regulations and industry codes

Kenntnisse

IT systems management

GxP compliance

engineering in IT systems

troubleshooting IT systems

COBIT/ITIL/GAMP/21CFR Part 11

API processes & batch sequencing

validation & verification

statistical analysis

GxP documentation practices

regulatory audits & inspections

Ausbildung

Bachelor's degree in Information Technology or related field

Jobbeschreibung

Novo Nordisk in New Hampshire, West Lebanon, seeks an experienced IT systems lead to independently manage API automation and IT systems through their lifecycle, ensuring compliance with GxP, data protection, and company requirements. The role involves validation, maintenance, risk assessment, change control, and incident resolution to support reliable operations.

You will collaborate with IT Security and SMEs to document controls, coordinate validation testing (IQ/OQ/PQ, FAT/SAT/UAT), and