IT Compliance Analyst - SDF

Novo Nordisk AS

Durham, NC

JOB DETAILS
SKILLS
Analysis Skills, Architectural Services, Automation, Biotech and Pharmaceutical, Business Continuity Planning (BCP), Business Processes, Capital Project, Change Order Management, Change Requests/Orders, Chronic Disease, Code of Federal Regulations, Communication Skills, Computer Security, Dental Insurance, Diabetes, Disability Insurance, Disease, Dosage Forms, Drug Manufacturing, Emerging Technology, Environmental Regulations, FDA Requirements, Health Insurance, Healthcare, Hewlett-Packard Product Family, Identify Issues, Information Technology & Information Systems, Information Technology/Systems Audit, Life Insurance, Maintain Compliance, Management of Information Systems/Technology (MIS), Manufacturing/Industrial Processes, Mentoring, Obesity, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Product Marketing, Production Support, Productivity Management, Project/Program Management, Quality Assurance, Regulations, Regulatory Compliance, Regulatory Requirements, Root Cause Analysis, Safety Training, Sales Pipeline, Software Development, Software Development Lifecycle (SDLC), System Operations, System Validation, Technical Leadership, Technical Support, Tuition Fees, Vision Plan, Willing to Travel, Writing Skills
LOCATION
Durham, NC
POSTED
13 days ago

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.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

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

Serve as ITs primary point of contact & subject matter expert (SME) on all IT related compliance policies & programs. Assist with the development & execution of key IT projects.

Relationships

Reports to Manager.

Essential Functions

  • Improve our capability to provide quality to all IT & automation processes by analyzing & improving the levels of compliance (Project management, Quality programs)
  • Ensure IT data systems are available, capable & accessible so that IT systems operate at the speed of business processes through quality initiatives & projects (ARE Management, business continuity & IT support)
  • Recommend & implement quality initiatives to meet the customer's needs, regulatory & internal compliance & add value to all business processes
  • Become subject-matter expert (SME) with NN validation software, eTIMs, within the IT team
  • Project management - develop & utilize skills necessary to develop, manage & implement IT projects of all sizes (small to large scale projects)
  • Follow all safety & environmental requirements in the performance of duties
  • Manage change requests & system validation for IT
  • Serve as IT lead for audits
  • Coordinate with QA Compliance Specialists to assure compliance with procedures & policies
  • Support & practice IT Security
  • Follow all safety & environmental requirements in the performance of duties
  • Comply with internal & external regulations & procedures
  • Follow all safety and 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

  • Bachelors Degree in Information Technology, Engineering or Automation from an accredited university is required. Master's degree in a relevant field preferred
  • Minimum of 5 years of IT experience, with some experience working in a pharmaceutical manufacturing environment required
  • Experience with software development concepts required
  • Proven experience with quality systems & proven problem solving skills required
  • Excellent organizational skills & written/verbal communication skills required
  • Knowledge of FDA regulations & guidelines as they relate to computer-based information systems required
  • In-depth knowledge & training on compliance policies, programs & procedures as well as regulatory requirements, such as 21 CFR Part 11, electronic records retention, configuration items lists, revalidation, etc required
  • Experience with quality procedures such as non-conformities, change requests & IT system validation required
  • Serve as the liaison between IT & Automation, internal & external QA organizations & other IT auditing organizations required
  • Knowledge of pharmaceutical manufacturing business processes & how IT & automation integrate with them required
  • Excellent troubleshooting skills; ability identify root cause of a problem & assist in determining appropriate IT or technical solutions required
  • Demonstrated skills in identifying & leading medium to large scale IT validation projects required
  • Possesses & applies a broad range of expertise of principles, methods, practices, standards, procedures & compliance requirements of a particular business function in designing & developing complex IT solutions required
  • Provides solutions which are aligned with site strategies & comply with the company's architectural & operating standards & requirements required
  • Experience with developing & maintaining IT-focused policies, procedures & other documents required
  • Experience with HP Application Lifecycle Management software a plus
  • Project management & capital project experience strongly preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, were not chasing quick fixes - were creating lasting change for long-term health. For over 100 years, weve 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 whats possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, were 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.

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.

About the Company

N

Novo Nordisk AS

Working at Novo Nordisk

 

Life-changing careers

Starting a career at Novo Nordisk is more than getting a job. It is an opportunity to improve the lives of millions of people living with a serious chronic disease.

Whether you are a part of supplying insulin for patients around the world, discovering the next breakthrough at one of our state-of-the-art research centres, working with us is truly life-changing.

 

We are inspired by life

We are a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. Millions rely on us.

We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. From our colleagues in the lab, working to change lives through pioneering break-through treatments, to our colleagues putting sustainability at the core of our processes and working to prolong the life of our planet, this mission to improve lives is at the core of our every action.

 

Together we drive change

Change is a constant — change in lifestyle, change in technology, change all over. At Novo Nordisk, we don’t wait for change. We drive it.

We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.

That’s why we continuously push to improve the way we work and the lives of the patients we serve, creating innovative solutions that fit the way people want to live. To accomplish this, we embrace a spirit of open-mindedness and experimentation, striving for excellence without fixating on perfection.

 

Together, we are life-changing

Our company is our people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We want to ensure that every employee can achieve a work-life balance that supports their current priorities and where they want to go next.

 

Your development starts here

We value our employees for the unique skills, backgrounds and perspectives they bring to the table. We work continuously to help bring out the best in all of our people, offering opportunities for development and creating an environment of mobility within the company. We strive to offer a workplace that’s great to be in and to be from.

It is very important to us that anyone working with us feels empowered as an employee and as a person. We all should have the opportunity to act fast, make decisions and be agile. 

With a career at our company, you will feel a difference right from the start. A sense of inspiration that comes from a shared belief in driving positive change for people, families and communities everywhere, and it’s a collective effort. We rely on the joint potential and collaboration of our more than 45,000 employees.

In the video above, meet  Marie Darting, one of our scientists, and hear more about her work as a formulation scientist, her perspective on development plans and the impact she feels her work has on people living with a chronic disease.

 

Who we are

We were founded in 1923 and today we are a global healthcare company headquartered just outside Copenhagen, Denmark.

Our purpose is to drive change to defeat diabetes and other serious chronic diseases, such as obesity and rare blood and endocrine disorders. We do so by pioneering  scientific breakthroughs, expanding  access to our medicines , and working to prevent and ultimately cure diabetes.

With almost 100 years of experience, one of the broadest diabetes product portfolios in the healthcare industry, as well as an award-winning pipeline of innovative products, our success is built on our company values – the Novo Nordisk Way.

COMPANY SIZE
2,500 to 4,999 employees
INDUSTRY
Biotechnology/Pharmaceuticals
FOUNDED
1923
WEBSITE
https://www.novonordisk.com/