Associate Director, Quality Control

Novo Nordisk AS

Clayton, NC

JOB DETAILS
SKILLS
Analysis Skills, Asepsis, Biotech and Pharmaceutical, Budgeting, Business Ethics, Change Management, Chronic Disease, Cleaning Equipment, Coaching, Communication Skills, Computer Skills, Cross-Functional, Dental Insurance, Detail Oriented, Diabetes, Disability Insurance, Disease, Drug Manufacturing, Environmental Regulations, Equipment Maintenance/Repair, GMP (Good Manufacturing Practices), Health Insurance, Healthcare, Knowledge Transfer, Laboratory, Laboratory Analysis, Laboratory Equipment, Laboratory Operations, Laboratory Techniques, Leadership, Lean Manufacturing, Lean Six Sigma, Life Insurance, Maintain Compliance, Manufacturing, Materials Analysis, Mentoring, Microbiology, Obesity, People Management, Performance Management, Performance Metrics, Presentation/Verbal Skills, Problem Solving Skills, Process Capability, Process Development, Process Improvement, Process Validation, Product Marketing, Project Planning, Proofreading, Quality Control, Regulatory Compliance, Requirements Validation/Verification, Safety Training, Safety/Work Safety, Staff Development, Standard Operating Procedures (SOP), Strategic Planning, System Validation, Test Lab, Tuition Fees, Vision Plan, Willing to Travel, Writing Skills
LOCATION
Clayton, NC
POSTED
27 days ago

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. 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 Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you'll join a global network of manufacturing professionals who are passionate about what they do.

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

Lead strategic activities to drive line performance, process improvements & technical improvements within the assigned department. Ensure fulfillment of departmental targets in accordance with the Novo Nordisk Way while maintaining compliance with applicable regulations & SOPs. Manage all activities & personnel related to the establishment & operation of the laboratories supporting analysis of materials & products for the associated stakeholders.

Relationships

Reports to Vice President.

Essential Functions

  • Drive a safe workplace culture, ensuring safety & environmental requirements are met
  • Ensure processes are capable of meeting quality specifications & requirements
  • Drive alignment to annual P&O processes (Evolve, One Review, Talk-to Grow, etc.)
  • Focus on eliminating defects & building simplicity into processes
  • Align process activities with lead time targets
  • Set direction by developing transparent process objectives based on site goals
  • Drive process performance to meet business & customer needs
  • Drive operations standardization, equipment maintenance & compliance & collaboration across teams/departments for alignment
  • Use systems & coach employees to maximize value & minimize waste
  • Provide strategic resource planning to operate processes in a cLEAN way
  • Coach, develop and engage direct reports, focusing on the NNWay essentials
  • Integrate quality & business ethics into all decisions
  • Coordinate with head of department& other teams on workload issues & priorities
  • Frequent planning to ensure resources are in place to execute the plan, to include ensuring alignment with all budget/cost, quality and deliverables
  • Ensure tracking & reporting of KPIs
  • Communicate with customers and stakeholders to ensure knowledge transfer & alignment with all other relevant stakeholders
  • Follow all safety and environmental requirements in the performance of duties
  • Other accountabilities, 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.)

Development of People

Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

Qualifications

  • Bachelors Degree in science, engineering or related field of study from an accredited university required, with a minimum of seven (7) years of direct leadership/management experience in a clinical or industrial/pharmaceutical laboratory and a minimum of eight (8) years working in a manufacturing environment required, preferably a pharmaceutical manufacturing environment
  • Minimum five (5) years of analytical GMP laboratory experience required
  • Knowledgeable in one or more of the following areas: Microbiological or chemical testing, Laboratory Equipment, Validations/Transfers, Stability programs, GMPs, or laboratory techniques required based on assigned area
  • Experience driving process improvements/design using systematic methodologies, Lean principles, Six Sigma, etc., required
  • Demonstrated attention to detail, proofreading & strong computer skills with a willingness to learn new IT applications required
  • Demonstrated knowledge of US & ISO regulations & guidelines, & applications of cGMP's within microbial area based on assigned area required
  • Demonstrated knowledge of pharmaceutical industry validation requirements including a thorough understanding of cleaning, equipment, utility, computer & process validation requirements & concepts required
  • Excellent written & oral communication skills & the ability to author scientific & technical reports required
  • Organization/Planning: Proven expertise in leading execution of a process, planning/organizing, checking results & creating the cycle plan in accordance with testing needs required
  • Proven expertise in mentoring & staff development, change management, planning & organizing, managing execution & revising work plans for complex issues addressed by cross functional teams required

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/