Sr. IT Compliance - Business Analyst Job:
Novo Nordisk

Novo Nordisk
West Lebanon New Hampshire

Key responsibilities:
This role will be responsible for monitoring day-to-day usage operation and maintenance of computer systems. Job responsibilities include but are not limited to implementing and maintaining controls, processing and documentation to provide: confidentiality, integrity, availability, compliance and reliability of computer systems to support business operations.

Main job tasks:
  • Manage the seamless transition and handover of Projects with key stakeholders consistently.
  • Maintain system documentation and process according Novo Nordisk standards and in compliance with regulatory requirements in a structured way to facilitate rotation and consequently transition of systems from System Manager to System Manager.
  • Work in partnership with project managers to define interface agreements, SLAs and proper change management to move systems to operations.
  • Provide active/effective engagement, planning, communication and stakeholder management to transition of System Management roles and responsibilities from LoB.
  • 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.
  • Maintain list of IT vendors/suppliers including the criticality of the hardware, software and critical infrastructure for computer systems.
  • Develop and negotiate 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.
  • Facilitate risk management work in cooperation with stakeholders and department manager.
  • Maintain disaster recovery documentation and proper test and training of stakeholders.
  • Maintain 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)
  • Participate in 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.
Ensure proper planning, communication and documentation to retire systems according to requirements and regulations.
  • Assists with training, development, coaching, and recruitment for more junior level IT Analysts for Computer Systems.
  • 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.

Knowledge, skills & abilities and experience:
  • Bachelor’s Degree in relevant field (Computer Science or equivalent);
  • IIBA Certification ECBA or CCBA preferred

  • Minimum 8 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:
  • Ability to work independently and perform all activities in this job description in a consistent manner;
  • Excellent writing and communication skills, in English;
  • Strong ability to collaborate effectively in a team environment
  • High level capacity for Analysis, Synthesis and Evaluation.
  • 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

Physical requirements and work environment:
  • This position may lift up to 33lbs/15kg occasionally, and/or up to 10 pounds frequently or constantly to lift, carry, push, pull or otherwise move objects.
  • Repetition including substantial movement of wrists, hands, and or fingers.
  • The ability to speak, listen, and understand verbal and written communication.
  • The ability to stoop, kneel, crouch, reach, stand, and walk.
  • The ability to push, pull, lift, finger, and grasp.
  • Visual acuity to perform close activities such as: reading, writing, and analyzing; operating a motor vehicle or heavy equipment, and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations.
  • The working environment includes a variety of physical conditions including: noise, inside and outside conditions including temperature changes; atmospheric conditions including: odors, fumes, and dust.
  • Local and International Travel: 0-5%

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: 52561BR
State/Provinces: West Lebanon
Job Category: Information Technology

Basic Qualifications