Senior IT Validation & Compliance Lead

BioSpace

West Lebanon (NH)

On-site

USD 120,000 - 150,000

Full time

9 days ago

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Job summary

Novo Nordisk is seeking a Lead IT Validation & Compliance professional to ensure Computer Systems Validation and IT compliance across our West Lebanon site. This onsite role supports governance, quality, and patient safety by delivering validated IT solutions and continuous improvement.

The candidate should have strong regulatory knowledge (GAMP, 21 CFR Part 11), excellent communication, and leadership skills to mentor teams and coordinate with stakeholders.

Qualifications

Bachelor's degree in Information Technology or related field with at least 7 years IT compliance experience.
Master’s degree in Information Technology or related field preferred with at least 5 years IT compliance experience.
Minimum 5 years of Validation & Testing experience of IT solutions.
Experience with IT governance and compliance frameworks (GxP, 21 CFR Part 11, EU Annex 11).

Responsibilities

Provide subject matter expertise in Computer Systems Validation and IT compliance service delivery.
Ensure IT solutions compliance with regulatory requirements and Novo Nordisk standards.
Lead CSV activities including validation deliverables and risk assessments.
Collaborate with cross-functional teams to document and release validated IT systems.

Skills

Communication

Problem solving

Customer service

MS Office

Education

Bachelor's in Information Technology

Master’s in Information Technology (preferred)

Tools

HP ALM

Electronic lifecycle software

Job description

The candidate should have strong regulatory knowledge (GAMP, 21 CFR Part 11), excellent communication, and leadership skills to mentor teams and coordinate with stakeholders.

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