Senior IT Compliance Analyst - IT & OT - GMP
Skills
About the role
This is a senior IT compliance role at Novo Nordisk's Petersburg, Virginia site, supporting a new small-molecule API development and production facility. It suits an experienced IT compliance or validation professional in a GxP-regulated environment. The role ensures IT solutions meet regulatory requirements and supports validation, audits and inspections.
What you’ll do
- Develop and maintain validation and qualification documentation
- Conduct risk assessments and impact analyses to identify compliance issues
- Guide project teams on validation and qualification requirements
- Facilitate transition and handover of projects to service operations
- Participate as an IT SME in audits and inspections
- Collaborate with cross-functional teams to ensure IT solutions meet business needs on time and budget
- Coach and mentor personnel on compliance practices
What they’re looking for
- Bachelor's degree in IT, Engineering, Science or a related field
- 7 years of experience in IT compliance and 5 years in validation and testing of IT solutions
- Strong written and verbal communication skills in English
- Strong computer skills including expert-level Microsoft Office proficiency
- Ability to travel up to 10% of the time
Nice to have
- Master's degree with 5 years IT compliance and 3 years validation experience
- Certified Information Systems Auditor (CISA)
- Lean Six Sigma Green or Black Belt
- Experience serving as an SME supporting audits and inspections
- Experience in GxP, change management and deviation handling
- Experience with Incident, Problem and Change Management in IT
What’s on offer
- Leading pay and annual performance bonus
- 14 paid holidays
- Health, dental and vision insurance effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- 14 weeks paid parental leave and 6 weeks paid family medical leave
- Tuition assistance
- Life and disability insurance
Questions about this role
How many years of experience do I need?
The posting asks for a minimum of seven years in IT compliance and five years in validation and testing of IT solutions.
What benefits are offered?
The posting lists leading pay, an annual bonus, day-one health/dental/vision insurance, an 8% 401K match, paid parental leave and tuition assistance.
Is travel required?
Yes, up to 10% of the time, though the posting notes this can vary by role.
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