Director, Patient Safety Operational Excellence Lead

Novo Nordisk

Plainsboro, NJ

JOB DETAILS
SALARY
$181,670–$317,920 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


The Patient Safety, Compliance & Operational Excellence Lead is responsible for driving efficiency, quality, and innovation across US Quality, GxP Compliance Training and Patient Safety Operations. This role ensures that Safety/Quality/Training processes, systems, and resources are optimized to support regulatory compliance while enabling scalability, automation, and continuous improvement.





Relationships


Reports to the Executive Director, PS & GxP Business Operations. Accountable for establishing and managing relationships with local and global key stakeholders. May have direct reports or indirect reports.





Essential Functions



+ Operational Excellence & Process Improvement


+ Lead initiatives to streamline Safety/Quality/Training processes


+ Apply Lean Six Sigma or other methodologies to eliminate inefficiencies and improve throughput


+ Drive harmonization of workflows across affiliates, partners, and vendors




+ Performance Monitoring & Insights


+ Define and monitor Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs) for Safety/Quality/Training operations


+ Develop and maintain performance dashboards for leadership visibility


+ Provide insights and recommendations for proactive risk mitigation and capacity planning and allocations across internal and external resources




+ Technology & Innovation


+ Partner with appropriate departments to assist with the implementation and optimization of safety/quality/training systems


+ Drive adoption of digital tools (AI-assisted case processing, NLP, automation, analytics platforms)


+ Support system change control, validation, and upgrade activities




+ Governance & Change Management


+ Support Safety/Quality/Training leadership in operational and governance meetings


+ Lead cross-functional improvement projects with stakeholders from Quality, Regulatory Affairs, IT, and Global Units


+ Manage change initiatives to ensure successful adoption across global teams




+ Continuous Improvement & Compliance


+ Collaborate with Quality to address recurring CAPAs through process redesign and sustainable solutions


+ Conduct root cause analyses for deviations or performance issues


+ Promote a culture of continuous improvement and operational excellence








Physical Requirements


0-10% overnight travel required.





Development of People


Supervisory. Train, mentor, and guide direct or indirect team members to enhance their skills and competencies.





Qualifications



+ Bachelor’s degree required with a focus in Finance, Business Administration, or similar


+ Advanced degree preferred (MBA or other relevant advanced degree)


+ A minimum of 10 years’ experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting, with at least 5 of those working in or supporting a clinical, medical and/or regulatory organization, in the pharmaceutical industry (Pharma/Biotech/CRO)


+ Experience in leading teams (local required, global preferred)


+ Strong decision-making skills through demonstrated ability to leverage existing or forecasted data into strategy development, resource models, and optimization of plans for the organization


+ Ability to work independently or within teams in a global and agile environment; strong organization skills; able to streamline and simplify complex concepts for larger audiences


+ Demonstrated ability to identify risks and opportunities as they relate to resourcing strategies


+ Demonstrated analytical skills and critical thinking to resolve issues in a variety of complex situations requiring new solutions


+ Excellent written and verbal communication skills and the ability to be clear and concise in a variety of communication settings


+ Demonstrated ability to collaborate with local and global stakeholders to design and execute analyses to support decision-making and planning


+ Excellent skills in designing and implementing innovation/improvement initiatives, including change management


+ Advanced capability in MS Excel, MS PowerPoint and MS Word required






The base compensation range for this position is $181,670 to $317,920. 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/