GxP IT Systems Manager – API & Lifecycle Lead

Novo Nordisk A/S; Lebanon (NH); On-site; USD 110,000 - 170,000; Full time

Job summary

Novo Nordisk A/S in New Hampshire seeks an experienced IT systems manager responsible for automation and IT systems lifecycle across development, operation, maintenance, validation and retirement. You will collaborate with IT security and SMEs to ensure data integrity, security controls, and regulatory compliance.

Key duties include leading validation activities (IQ/OQ/PQ), maintaining documentation and change control, and coordinating cross-functional teams to meet project milestones while

Qualifications

• Bachelor’s degree in Information Technology or related field with 5+ years of IT systems management experience in regulated environments.
• Experience ensuring security, data integrity and retention per procedures.
• Familiarity with GxP, audits and inspections.
• Ability to lead validation and lifecycle activities for IT systems.

Responsibilities

• Manage requirements and controls for assigned systems per procedures and external requirements.
• Coordinate validation activities and testing (IQ/OQ/PQ) to demonstrate compliance.
• Develop lifecycle plans for systems including upgrades and retirement.
• Lead risk assessments and change control for assigned systems.
• Maintain system documentation, configurations, and baselines.
• Coordinate user access approvals and periodic reviews.
• Investigate complex incidents and implement corrective actions.
• Ensure compliance with healthcare laws and Novo Way principles.

Skills

IT systems management

Compliance awareness

Problem solving

Regulatory audits & inspections

GxP documentation practices

Education

Bachelor’s degree in Information Technology or related field

Tools

COBIT

ITIL

GAMP

21 CFR Part 11

PIC/S Annex 11

Job description

Novo Nordisk A/S in New Hampshire seeks an experienced IT systems manager responsible for automation and IT systems lifecycle across development, operation, maintenance, validation and retirement. You will collaborate with IT security and SMEs to ensure data integrity, security controls, and regulatory compliance.

Key duties include leading validation activities (IQ/OQ/PQ), maintaining documentation and change control, and coordinating cross-functional teams to meet project milestones while