Sr. QA Specialist - Pharmaceutical Manufacturing

Novo Nordisk AS

West Lebanon, NH

JOB DETAILS
SKILLS
Active Pharmaceutical Ingredient (API), Best Practices, Biology, Biotech and Pharmaceutical, Business Operations, Chronic Disease, Coaching, Communication Skills, Community Support, Consulting, Corrective Action, Cross-Functional, Data Analysis, Disease, Drug Manufacturing, English Language, GMP (Good Manufacturing Practices), Healthcare, Hemophilia, Internal Audit, Manufacturing, Medications, Mentoring, Needs Assessment, Negotiation Skills, Organizational Skills, Physical Demands, Policy Development, Presentation/Verbal Skills, Problem Solving Skills, Project Evaluation, Quality Assurance, Quality Control, Quality Management, Regulations, Support Documentation, Team Player, Testing, Training Program, Training Program Evaluation, Training/Teaching, Trend Analysis, Validation Documentation, Willing to Travel, Writing Skills
LOCATION
West Lebanon, NH
POSTED
30+ days ago

About the Department Site: New Hampshire, located in West Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's not your average production site - it's a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We're looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

The Position This position is responsible for working together with the management team to set future quality direction and supporting the implementation of our ambitious goals by bringing the best practices from other Novo Nordisk sites. The person in this role will be responsible for performing reviews/approving of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all site biologics produced. This position has QA signature authority on the review of individual batch records, supporting test records and other ancillary support records. Responsibility for developing and coaching QA colleagues as well as supporting manufacturing by being present on the manufacturing floor. This role will help drive implementation of quality improvement projects, and support cross functional projects across the site.

This role is based onsite at our West Lebanon, NH bio-production facility Monday-Friday. Our facility is a 24/7 commercial scale GMP manufacturing facility.

Responsibilities Reports to: Sr. Director, QA

Essential Functions

  • Responsible for training, mentoring and developing other QA colleagues
  • Responsible for identifying and assessing training needs and delivering training materials and programs, to include training of team members on compliance related issues and other QA related topics
  • Serve as Good Manufacturing Practice (GMP) expert that responsible for evaluating and improving the effectiveness of training programs
  • Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal audits of the facility, and deviation issues
  • Informing stakeholders regarding project goals and deliverables
  • Consult and mentor across business operations and provide specialized knowledge
  • Reviews and assesses Deviations, including evaluation, tracking, follow-up, and reporting / trending
  • Reviews and approves Validation Documentation
  • Reviews and assesses Corrective and Preventive Action Reports
  • 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
  • Other duties as assigned

Qualifications Education and Certifications:

  • Bachelor's Degree within a scientific or life science required
  • Master's Degree preferred

Work Experience:

  • Bachelor's Degree with ten (10) years experience required
  • Master's Degree with eight (8) years experience preferred
  • Six (6) years of direct QA experience preferred

Knowledge, Skills, and Abilities:

  • Excellent written and verbal communication and negotiating skills in English are required
  • Strong planning and organization skills, with flexibility for changes in work priorities
  • Must be able to exercise judgment within defined practices and policies to determine appropriate action to be taken
  • Normally receives no instructions on routine work, and general instructions on new assignments
  • Determines and develops approach to solutions
  • Ability to work on complex Quality projects where analysis of data requires evaluation of identifiable factors
  • Ability to train and/or mentor Junior team members in QA
  • Extensive knowledge in GMP API manufacturing in the pharmaceutical Industry
  • Have proven experience with GMP manufacturing in the pharmaceutical industry
  • Good stakeholder management skills and collaboration skills at all levels of the organization

Physical Requirements Local and International Travel: 0-5%. While performing this job employee work involves sitting most of the time with walking and standing required only occasionally. This position may lift up to 10 pounds occasionally or constantly to lift, carry, push, pull or otherwise move objects. Visual a to perform close activities such as: reading, writing, and analyzing.

We Commit to Inclusion We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we are not chasing quick fixes - we are creating lasting change for long-term health. For over 100 years, we have 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, we are 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/