Loading...

Systems Manager

Facility:  Information Technology & Telecom
Location: 

Clayton, NC, US

About the Department

At Novo Nordisk, we want to make a difference. For more than 95 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Help us bring quality to life. Our filling and finishing facility (DFP) is a 457,000 square foot aseptic "fill and finish" manufacturing facility located in Clayton, NC and employs more than 850 people. The facility is part of a global network of manufacturing sites responsible for several key steps in the diabetes treatment manufacturing process, including sterile formulation, filling, inspection, device assembly and packaging. Producing medicines is a special responsibility. Our employees are passionate about what they do, knowing that their work makes a difference to millions of people who rely on our products every day. Are you ready to make a difference?

 

Position Purpose

Responsible for system management of assigned regulated IT Systems. This includes the full systems life cycle management including system development, system maintenance & operation, compliance to regulatory & Novo Nordisk requirements, incident & change management & retirement of systems. Responsible for overview & control of the life cycle management of production manufacturing IT systems as assigned. Prepares & drives support agreements/SLAs with vendors & internal customers.

 

Ensures optimal processes within maintenance & operation of a regulated system according to relevant regulatory authorities (GxP, Financial & Personal Data Protection). Responsible for change control & configuration management of systems. Responsible for system documentation including specifications, operational manuals, system architecture, data flows, & system assessments. Ensures user training & user support is in place.  Responsible for system change management & security management.

 

Ensures data integrity & system continuity planning.  Performs system evaluations as required. Leads incident & problem investigations using Lean methodology & ensures quality deviations are remediated with appropriate effective corrective actions to ensure non-recurrence. Ensure that the systems are in compliance with relevant internal & external requirements (21CFR Part 11, Annex 11, HIPAA, and SARBOX).  Maintains system documentation for GxP critical IT systems.  Ensures appropriate testing (i.e., FAT, SAT, UAT, IQ, OQ, PQ, &/or GEP) is in place to ensure IT requirements are met. Represents IT systems in connection with audits & inspections.

 

May lead cross-functional project teams for process improvement.  Demonstrates extensive knowledge of & experience with regulatory requirements. Ensures continued & improved overall user satisfaction with system.

 

Accountabilities

  • Systems Management:
    • Ensures system compliance with relevant internal SOPs & guidelines as well as external requirements (21CFR Part 11, Personal Data Protection, SARBOX, etc.)
    • Reviews & maintains all IT CSV Validation/System Decommissioning documentation in accordance with regulatory & Novo Nordisk requirements
    • Provides input on System Life Cycle management & suggests inputs for the IT roadmap
    • Documents Operation & Maintenance of the system (incident management, contract/SLA Management, data integrity/retention/archive, continuity/recovery plans)
    • Performs system reviews to ensure basic IT controls are in place & in control to ensure compliance/security of the system
    • Reviews & approves testing protocols to ensure requirements are tested appropriately
    • Participates in Root Cause Analysis for deviations within supported IT Systems to ensure effective corrective actions are identified & implemented
    • Audit & Inspection support
  • Documentation
    • System documentation including ensuring operational manuals, system architecture, data flows, etc. are complete
    • Works with Subject Matter Expert (SME) to ensure system documentation is in compliance with local, corporate & regulatory regulations
    • Documentation of system configuration baselines
  • Security
    • Approves appropriate access to new users & removes access as necessary
    • Works with IT Security/SME to ensure controls are in place & documented
    • Performs annual system evaluation
  • System Support
    • Serves as the escalation point for system support
    • Ensures end user training is in place as required
    • Prepares support agreements with internal & external sources.
  • System Projects: Performs activities assigned within agreed timelines
  • Maintains a safe work environment
  • Other accountabilities, as assigned

 

Education

BA/BS degree in Computer Science or Engineering, or similar applicable technical degree in relevant field or 5 years pharmaceutical IT system management experience focusing on compliance.

 

Required Experience

  • Minimum of five (5) years of operation & maintenance of IT systems preferably within the pharmaceutical industry
  • Experience with production manufacturing, IT Projects & management of IT systems

 

Technical/Process/Functional Knowledge

  • Understanding of & knowledgeable in the following areas:
    • IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11, and/or PIC/S Annex 11
    • System development lifecycle including validation of computer systems, operation & maintenance & decommissioning of systems
    • Manufacturing processes for manufacturing areas (aseptic, inspection, assembly, packaging, utilities & laboratories).
  • Expert in GxP documentation practices
  • Proficient in basic computer skills including experience in the use of Microsoft Office
  • Ability to independently review & approve protocols & technical documents in compliance with regulatory & Novo Nordisk requirements
  • Excellent oral & written communication skills
  • Experience in regulatory audits & inspections
  • Experience in project teams driving deliverables, tasks, & activities for computer system validation
  • Expert in utilizing appropriate root-cause analysis tools & techniques

 

Organization/Planning

Demonstrated expertise in planning/organizing, managing execution, checking results & revising the work plan for complex problems being resolved by cross functional teams.

 

Physical Requirements

  • Occasionally moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions
  • Constantly operates a computer & other office equipment using hands
  • Able to work in an open office environment with the possibility of frequent distraction
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation

 

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

 

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.