Senior Patient Safety and GxP Document Oversight Manager

Novo Nordisk

Plainsboro, NJ

JOB DETAILS
SALARY
$116,810–$216,100 Per Year
LOCATION
Plainsboro, NJ
POSTED
30+ days ago


About the Department





The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?








The Position


We are seeking a highly organized and detail-oriented Business Process Oversight Manager to oversee all aspects of Good Practice (GxP) documentation management within our organization. This role will be responsible for ensuring that all GxP-related documentation is accurately maintained, routinely reviewed, and compliant with regulatory requirements. The ideal candidate will have a strong background in documentation management, process oversight, and regulatory compliance within the pharmaceutical or biotechnology industry.





Relationship


This job reports to the Senior Director of the GxP Compliance & Technical Operations or the Director, GxP Compliance, Patient Safety, & Vendor Oversight. This job will interact with Patient Safety, Quality, Vendor and Contract Management, IT, Finance, Contract/Supplier of Customer Engagement Programs, and other CMR Functional areas. This job will lead a team of Patient Safety training and vendor training oversight managers and or technical writers and interact with internal and external stakeholders.





Essential Functions



+ GxP Documentation Management


+ Develop and implement comprehensive documentation management systems and processes for all GxP documentation, ensuring adherence to regulatory standards


+ Maintain an up-to-date inventory of GxP documents, including Standard Operating Procedures (SOPs), Work Instructions (WIs), and other essential compliance documentation


+ Coordinate document reviews, approvals, and revisions, ensuring timely updates and compliance with internal and external requirements


+ Monitor and track the lifecycle of GxP documents to ensure they are effectively managed, properly archived, and readily accessible when needed


+ Key Area #1 Process Oversight and Compliance


+ Establish and enforce GxP documentation standards and best practices across the organization, ensuring consistency and compliance with FDA, EMA, and other regulatory guidelines


+ Conduct regular audits of GxP documentation to verify compliance and identify areas for improvement or corrective actions


+ Collaborate with cross-functional teams to ensure that GxP documentation practices are integrated into operational processes and compliant with industry standards


+ Serve as a subject matter expert on GxP documentation requirements, providing guidance and support to staff across departments




+ Key Area #2 Training and Education


+ Develop and implement training programs on GxP documentation best practices and regulatory requirements for employees at all levels


+ Facilitate workshops and seminars to enhance staff awareness of GxP documentation standards and the importance of compliance


+ Evaluate training effectiveness and make adjustments to programs as needed to improve overall understanding and adherence




+ Key Area #3 Performance Monitoring and Reporting


+ Define key performance indicators (KPIs) for GxP documentation management and conduct regular assessments to track performance against established metrics


+ Prepare and present regular reports on documentation compliance, audit results, and improvement initiatives to senior management


+ Lead continuous improvement initiatives related to GxP documentation processes, leveraging data-driven insights to enhance efficiency and effectiveness








Physical Requirements


Approximately 20% overnight travel.





Qualifications



+ Bachelor's degree in a relevant field (Life Sciences, Quality Assurance, Regulatory Affairs, etc.); advanced degree preferred


+ 7+ years of experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or biotechnology industry


+ Strong knowledge of GxP regulations, documentation standards, and industry best practices


+ Proven experience in auditing, process improvement, and implementing documentation management systems


+ Excellent organizational, analytical, and problem-solving skills, with attention to detail


+ Strong interpersonal and communication skills, capable of collaborating effectively with cross-functional teams


+ Proficiency in documentation management software and Microsoft Office Suite (Word, Excel, PowerPoint)









Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.





The base compensation range for this position is $116,810 to 216,100. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.





Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.





Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.





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





We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.





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

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/