Senior IT Compliance Analyst - IT & OT - GMP

BioSpace; Petersburg (VA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Competitive pay + annual bonus

PTO & paid holidays

Health, dental, vision insurance

8% 401K company match

Parental & family leave

Tuition assistance

Life & disability insurance

Referral rewards

Job summary

Novo Nordisk in Petersburg, VA is seeking an IT compliance specialist to lead validation and qualification efforts across IT solutions. The role focuses on regulatory alignment, risk mitigation, and process improvement to safeguard product quality, patient safety, and data integrity.

You will partner with cross-functional teams to ensure on-time, on-budget delivery and compliant documentation throughout the life cycle, including audits and inspections. Travel up to 10% may be required.

Qualifications

• Bachelor’s degree in IT, Engineering, Science or related field with 7+ years IT compliance experience and 5+ years in validation/testing.
• Master’s degree in IT/Engineering/Science with 5+ years IT compliance and 3+ years validation/testing experience, preferably in pharma.
• Excellent English communication; strong collaboration and problem-solving skills.

Responsibilities

• Develop and maintain validation and qualification documentation.
• Conduct risk assessments and impact analyses to identify compliance issues and mitigation strategies.
• Guide project teams on validation requirements and ensure regulatory compliance.
• Monitor and improve documentation and processes for regulatory compliance and Novo Nordisk standards.
• Lead seamless handover of projects to service operations with stakeholders.
• Maintain system docs per Novo Nordisk standards and regulatory rules.
• Support audits and inspections with SME expertise and documentation.

Skills

IT compliance

Validation & Testing

Communication

Team collaboration

Problem solving

Planning & organization

MS Office

Education

Bachelor’s degree in IT/Engineering/Science

Master’s degree in IT/Engineering/Science

Job description

About The Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET´s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.

What We Offer You

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

The Position

Provide subject matter expertise in IT compliance, process improvement, and IT compliance service delivery management across the site. Ensures that IT solutions are compliant with relevant regulations and standards and facilitates the seamless transition and handover of projects to service operations with key stakeholders. Ensures governance and continuous improvement as an enabler supporting product quality, patient safety, and data integrity, and contributes to the organization's goals of improving the lives of people with chronic diseases.

Relationships

Reports to Manager.

Essential Functions

• Develop and maintain validation and qualification documentation
• Conduct risk assessments and impact analyses to identify potential compliance issues and develop mitigation strategies
• Provide guidance and support to project teams on validation and qualification requirements
• Continuously monitor and improve documentation and processes to ensure compliance with regulatory requirements and Novo Nordisk standards
• Facilitate the seamless transition and handover of projects to service operations with key stakeholders
• Maintain system documentation and process according to Novo Nordisk standards and in compliance with regulatory requirements
• Participate as an IT SME in audits and inspections and provide needed documentation to demonstrate validated state and proper management of IT solutions throughout the life cycle
• Collaborate with cross-functional teams to ensure that all IT solutions meet business needs, are delivered on time & within budget, are properly documented, and managed throughout their life cycle
• Ensure that all IT solutions, documentation, and processes are following regulatory requirements and Novo Nordisk standards
• Provide leadership and expertise in IT compliance, process improvement, and project coordination
• Coach and mentor personnel, and provide guidance as needed
• Participate in process group meetings and contribute to process group activities
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Physical Requirements

May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12 hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections. Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. % can change on a case-by-case basis based on the role.

Qualifications

• Bachelor’s Degree in IT, Engineering, Science, or relevant field of study from an accredited university with a minimum of seven (7) years of experience in IT compliance and five (5) years of experience in Validation and Testing of IT Solutions required, preferably within the pharmaceutical industry
• Master’s degree in IT, Engineering, Science, or relevant field of study from an accredited university preferred with a minimum of five (5) years of experience in IT compliance and three (3) years of experience in Validation & Testing of IT solutions, required; preferable within the pharmaceutical industry
• Excellent written and verbal communication skills in English
• Strong customer service skills and ability to collaborate effectively in a team environment
• Excellent problem solving, negotiation, conflict management, and interpersonal skills
• Excellent planning, organizing, decision making and deal with complexity and ambiguity
• Strong computer skills and expert-level proficiency in Microsoft Office (MS Office)

Preferred Qualifications

• Certified Information Systems Auditor (CISA)
• Lean Six Sigma (Green Belt 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

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.