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Computer Systems Compliance Specialist Job
Novo Nordisk | West Lebanon, New Hampshire
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Job Description

Requisition ID 49756BR
Title Computer Systems Compliance Specialist
Job Category Quality
Job Description

This position will be responsible for reviewing IT processes, documentation and validation records to assure that all relevant processes are compliant with local and corporate procedures. The position will also review the processes and documentation of the Automation Engineering group. This position has QA signature authority on the review of change control, computer system validation documents, and other ancillary records supporting the IT and Automation groups. Support of health authority inspections and internal audits with a focus on 21 CFR Parts 210, 211, and 11; EU GMP Annex 11, GAMP and compliance of IS-related quality systems.


Reports to: Sr. Manager, Quality Assurance.

Main Job Tasks:
* Support, review and approve IT and automation policies and procedures required to ensure compliance with applicable regulatory requirements (GxP, Part 11).
* Partner with local and global team members for validation and compliance activities around current and future Enterprise Systems and Laboratory Information Management (LIMS) and Quality Management (QMS) systems.
* QA signature authority to review and approve site wide computer system validation protocols and reports.
* Acquire necessary training to process Change Control, CAPAs, deviations, exceptions and investigations related to IT, automation and ERP 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.
Physical Requirements:

Travel: 0-10%

Knowledge, Skills and Experience:

* Bachelor's degree or equivalent experience. Professional certification or training in Information Systems (IS)/Technology/Automation related compliance within an FDA, EMEA,or similar regulated industry including GxP validation and compliance.
* Requires a minimum of five (5) years of experience in an FDA regulated environment with broad knowledge of regulatory compliance in IS infrastructure and Enterprise Systems (i.e., networks, ERP, manufacturing, quality management and LIMS systems).
* Experience and/or training in IS compliance, computer system validation and risk management.
* Experience working in Quality Assurance, with background of key quality system elements such as good documentation practices, change control, non-conformities/CAPA, and validation.

Position Location US - Lebanon, NH
City West Lebanon
State/Provinces US - NH

At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle - helping us find the right balance between compassion and competitiveness

With a career at Novo Nordisk, you'll feel a difference right from the start. It's a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!

Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

If you are interested in applying for employment with Novo Nordisk and need special assistance or an accommodation to use our website or to apply for a position, please call the U.S. Toll Free number at 1-855-411-5290 or click on the following link to submit your request: https://www.surveymonkey.com/r/novoaccommodation. Please note we do not accept applications for employment or employment related solicitations through this site. If you are requesting special assistance, please specify your request by selecting "Yes" in Question 2 on the site. We will not be able to respond to requests unless you specify the need for special assistance or an accommodation in Question 2. Determinations on requests for reasonable accommodation are made on a case-by-case basis.

About Novo Nordisk

Novo Nordisk A/S is a Denmark-based healthcare company. The Company provides diabetes care and is engaged in haemostasis management, growth hormone therapy and hormone replacement therapy. The Company manufactures and markets pharmaceutical products and services to patients, the medical profession and society. The Company is organized in two segments: diabetes care and biopharmaceuticals. Diabetes care includes discovery, development, manufacturing and marketing of products within the areas of insulin, glucagon-like peptide (GLP)-1 and related delivery systems, as well as oral antidiabetic products (OAD). Biopharmaceuticals includes discovery, development, manufacturing and marketing of products within the therapy areas haemostasis management, growth hormone therapy, hormone replacement therapy, inflammation therapy and other therapy areas.

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