Compliance Support Area Specialist

Facility:  Quality
Location: 

Clayton, NC, US

About the Department

At Novo Nordisk, we want to make a difference. For nearly 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

 

In Clayton, NC, we now operate two adjacent pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. 


Our Clayton, NC Injectable Finished Products (IFP) facility is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. When you work at IFP, you’ll join a global network of manufacturing professionals focused on several key, final production processes, including sterile formulation, filling, inspection, device assembly and packaging.

 

At IFP, our employees are passionate about what they do, knowing their work makes a difference to millions of people who rely on our products every day. After all, producing medicines is a special responsibility.

 

Join Team Novo Nordisk and help us make what matters.

 

Position Purpose

Develop & maintain quality & compliance processes for Production Support. Ensure good execution & monitoring according to FDA’s Good Manufacturing Practices (GMP) requirements.

 

Accountabilities

  • Ensure compliance with Regulations, ISO standards & corporate/local SOPs
  • Coordinate tasks with QA & LoB to ensure compliance with company procedures, policies & objectives
  • Develop metrics & analyze trends for Quality System process improvements, SPS, deviations & CAPA investigations
  • Write & review validation, deviations, change control & other quality-related documentation for completeness & accuracy
  • Utilize continuous improvement tools for Quality & Compliance operations to drive performance
  • Provide guidance regarding quality-related activities.  Support users in the Quality Management Systems
  • Support site-wide cross-functional investigations, systematic problem-solving & process improvements
  • Initiate & support compliance-related process confirmations & Go-Look-Sees
  • Responsible to identify preventive actions to eliminate compliance gaps
  • Establish, monitor & process-confirm internal department compliance plans & self-audit/inspection readiness processes
  • Support project teams as a compliance resource. Monitor change management efforts & report project performance to the relevant stakeholders
  • Responsible for execution & timely completion of quality-related return-to-service deliverables during site shutdown periods. Report performance to relevant stakeholders
  • Perform other duties, as assigned

 

Desired Qualifications

  • BA/BS in Life Sciences, Engineering, or related field, or an equivalent combination of education & experience
  • Minimum of five (5) years of work experience in pharmaceutical manufacturing, or other regulated industry
  • Demonstrated expertise in regulations & quality systems (e.g. product disposition, NC/CAPA, Change Control, Audits, Validation, etc.)
  • Demonstrated knowledge of NN processes & quality systems
  • Demonstrated experience leading process improvements
  • Demonstrated experience leading Kaizen and/or cross-functional process improvements
  • Demonstrated experience in training and coaching others
  • Expert knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs in biopharmaceutical manufacturing
  • Excellent written & verbal communication skills
  • High level of proficiency in MS Office, MS Project, PowerPoint, etc.
  • Demonstrated experience in solving problems & process improvements
  • High competency with regard to LEAN tools
  • Demonstrates excellence in time management, organizational & project management skills

 

Physical & Other Requirements

  • Occasionally moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions
  • Constantly operates a computer & other office equipment using hands
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation
  • Able to work in an open office environment with the possibility of frequent distraction

 

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

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 

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.

 

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

 

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.