IT System Manager III - API manufacturing

BioSpace; Petersburg (VA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Leading pay & annual bonus

Paid time off & holidays

Health, dental, vision insurance

401K with company match

Parental leave

Job summary

Novo Nordiskis seeking a Senior IT Systems Governance professional at our Petersburg, VA site to manage governance, lifecycle, validation, and compliance for critical IT systems. The role requires ensuring regulatory adherence, leading cross-functional teams, and coordinating validation activities with SMEs.

Extensive experience in GxP, audits, and IT frameworks is essential. The position offers competitive pay, comprehensive benefits, and growth opportunities within a global pharmaceutical

Qualifications

• Bachelor's Degree plus 7+ years of IT systems operation experience in pharma or related industries.
• Alternative: Associate’s Degree plus 9+ years of IT systems operation experience.
• Alternate: High School Diploma plus 11+ years of IT systems operation experience.
• Experience supporting and troubleshooting automation/IT systems & batch processes.
• Experience in system development lifecycle including validation of computer systems and lifecycle management.
• Proficient at troubleshooting automated/IT system issues including interfaces & hardware components.
• Expert level in GxP documentation practices.
• Excellent oral and written communication skills; regulatory audits/inspections experience.
• Experience in project teams driving deliverables and validation activities.
• Understanding IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11, PIC/S Annex 11.
• Functional knowledge of API processes and batch sequencing.
• Statistical analysis for problem solving is a plus.
• Leadership and cross-functional coordination preferred.

Responsibilities

• Manage IT system governance and ensure regulatory compliance across systems.
• Oversee system lifecycle management and validation activities.
• Drive project schedules and coordination with SMEs for IT roadmap.
• Manage change control with a risk-based approach and approvals.
• Review and approve testing protocols to ensure requirements are tested.
• Maintain system documentation and configuration baselines.
• Support audits, inspections, and periodic evaluations.
• Lead cross-functional teams for process improvement when needed.

Skills

Governance

IT Security

Regulatory compliance

System validation

Change control

Documentation

Cross-functional leadership

Vendor management

Education

Bachelor's Degree in CS/Engineering

Associate’s Degree in CS/Engineering

High School Diploma or equivalent

Tools

COBIT

ITIL

GAMP

21 CFR Part 11

PIC/S Annex 11

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.

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

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

The Position

Manage the governance, provide project oversite, drive the schedule & ensure adherence to the documented requirements for system management of assigned IT Systems. This includes the full system lifecycle management process (system development, system maintenance & operation, compliance with regulatory & Novo Nordisk requirements, incident & change management & retirement of systems). Ensure processes are in place for system maintenance & operation according to relevant regulatory authorities (GxP, Financial, Personal Data Protection, etc.).

Relationships

Reports to Senior Manager.

Essential Functions

• Manages the IT system requirements by ensuring system compliance with relevant SOPs and guidelines, as well as external requirements (system security, audit trail, data integrity/retention/archival/restoration, patching, system monitoring, system continuity & contingency plan, etc.)
• Works with IT Security/SME to ensure appropriate system security controls are in place & documented
• Ensures appropriate validation approach & qualification testing is in place to ensure IT requirements are met (i.e. FAT, SAT, UAT, IQ, OQ, PQ, and/or GEP)
• Manages the system lifecycle process & provides strategic perspective for the IT roadmap
• Manages the system change control with a risk-based approach
• Reviews & approves testing protocols to ensure requirements are tested appropriately
• Manages the system configuration & supports determining the configurable items that are documented in the configuration baseline standards
• Manages the system documentation (operation & maintenance standards, specifications, configuration baselines, instructional manuals, system architecture, data flows, system assessments, etc.)
• Works closely with Subject Matter Expert (SME) to ensure system documentation complies with local, corporate & regulatory regulations
• Ensures user training & user support are in place
• Manages the approval of access for new users & performs user access reviews to determine access removal
• Ensures continued & improved overall user satisfaction with system
• Occasionally, leads cross-functional project teams for process improvement
• Works closely with SME to understand & determine solutions for IT incidents & deviations, to ensure effective corrective actions are identified & implemented to prevent incident recurrence
• Establishes support standards & processes (internal & external support contracts/service level agreements (SLA), licensing contracts, incident handling, etc.)
• Serves as primary escalation point for system support, improvements & projects
• Ensures that the validated state is maintained & monitored according to the established requirements by managing the Periodic System Evaluations (PSE) & reviewing system data to ensure IT controls are actively functioning as designed to ensure compliance with the documented system requirements
• Evaluates system alarms, user access, deviations & trends
• Supports audits & inspection.
• Manages the project portfolio for the system (software upgrades, managing hardware obsolescence, retirement, etc.).
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Physical Requirements

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 computer science, engineering or related field from an accredited university and a minimum of seven (7) years of experience in operation & maintenance of IT systems required, preferably within the pharmaceutical industry
• In lieu of Bachelor’s Degree and seven (7) years of experience, may consider an Associate’s Degree in computer science, engineering or related field from an accredited college or university and a minimum of nine (9) years of experience in operation & maintenance of IT systems required, preferably within the pharmaceutical industry
• In lieu of Bachelor’s Degree and seven (7) years of experience, may consider a High School Diploma or equivalent and a minimum of eleven (11) years of experience in operation & maintenance of IT systems required, preferably within the pharmaceutical industry
• Experience supporting and troubleshooting automation/IT systems & batch processes required
• Experience in system development & lifecycle management including validation of computer systems, operation & maintenance, & decommissioning of systems required
• Proficient at troubleshooting (systematic problem solving) automated/IT system issues, including interfaces & hardware components required
• Expert in GxP documentation practices required
• Excellent oral & written communication skills required
• Experience in regulatory audits & inspections required
• Experience in project teams driving deliverables, tasks, & activities for computer system validation required
• Understanding of IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11, and/or PIC/S Annex 11 preferred
• Functional knowledge of API processes & batch sequencing preferred
• Functional understanding of the application of statistical analysis to problem solving preferred
• Demonstrated expertise in planning/organizing, managing execution, checking results, & revising the work plan for complex problems being resolved by cross functional teams preferred

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.