Site New Hampshire, located in West Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's not your average production site - it's a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We're looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential? |
We have an exciting new opportunity to join our growing team in an IT Compliance role. Looking for a motivated self starter with a background in technical writing and IT Compliance. If this is sounds like you.. apply today!!
Main job tasks:
- Support the transition and handover of Projects with key stakeholders.
- Maintain system documentation and process according Novo Nordisk standards and in compliance with regulatory requirements in a structured way to facilitate rotation and consequently support the transition of systems from System Manager to System Manager.
- Collaborate with project managers to define interface agreements, SLAs and proper change management to move systems to operations.
- Support daily IT Operations including but not limited to: general support; vendor management; change and release management; archiving and retention of computer system documentation and data; risk management and security; validation and training.
- Provide follow-up on Incidents, Service Requests, Problems, Change Requests and Remarks/NCs. Ensure communication, action and escalation on issues that impact system Confidentiality, Integrity, Availability, Compliance and Reliability.
Knowledge, skills & abilities and experience:
- Maintain list of IT vendors/suppliers including the criticality of the hardware, software and critical infrastructure for computer systems.
- Coordinate with IT Manager on vendor Service Level Agreements regarding system support.
- Follow-up on vendor deliveries and services according to agreements.
- Maintain SLA's and IT Service catalog.
- Ensure proper documentation, testing, communication and stakeholder management for changes.
- Provide continuous follow-up on system component life-cycle ensuring proper maintenance and system strategy.
- Archive and retain documentation and data according to requirements.
- Assist risk management work in cooperation with stakeholders and department manager.
- Support disaster recovery documentation and proper test and training of stakeholders.
- Support required controls to ensure system security.
- Ensure that the systems are in compliance with relevant internal and external requirements (cGMP, 21CFR Part 11 and overall instructions).
- Support audits and inspections and provide the needed documentation to demonstrate validation state and proper management of the systems though the life-cycle.
- Create and maintain system documentation for GxP computer systems.
- Test IT requirements for GxP computer systems.
- Perform, prepare and maintain training material, including but not limited to SOPs, Guidelines and class training material.
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.
- Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others.
- Bachelor's Degree in relevant field (Computer Science or equivalent);
- IIBA Certification ECBA or CCBA preferred
- Minimum 3 years' experience on operation and maintenance of IT systems, preferably within the pharmaceutical industry;
- Experience with validating and qualifying IT systems in GxP and non GxP environments, performing and executing validation documentation and testing protocols (IQ/OQ/PQ/UAT)
Skills & abilities:
- Excellent writing and communication skills, in English;
- Strong 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 ambiguity;
- Strong computer skills and MS Office Expert
Title and pay will be commensurate with experience!
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.
Requisition ID: 57754BR
State/Provinces: West Lebanon
Job Category: Information Technology