Senior Quality Assurance, QMS & Validation Area Specialist

Facility:  Quality
Location: 

Durham, NC, US

About the Department

For almost 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes. Being part of Novo Nordisk, we offer our employees life-changing careers and the opportunity to improve the quality of life for millions of people around the world. 

 

Working at our Oral Finished Products (OFP) tableting facility in Durham, NC you will help meet the growing demand for our treatments, specifically supporting innovative oral treatments for patients with type 2 diabetes. 

 

Our facility sits on 194,000 square feet of state-of-the-art equipment and we currently employ approximately 75 passionate and committed employees working across Bulk Production, Packaging, Warehouse, Business Support, QC and QA. 

 

Join OFP Site Durham and help us make a difference for the people who rely on our products every day. Here, you will work with the best manufacturing professionals in the industry. Are you ready for a life-changing career?

 

Position Purpose

Primary responsibility is to provide quality review & approval of validation activities associated with changes to existing systems & projects that support OFP Site Durham. Support protocol development & approval, investigations for deviations & champion local, corporate & regulatory standards:

  • Presentation & support for validation concepts & approaches with audits & inspections
  • Provide Quality validation review & approval through the preparation, execution, data analysis & report writing for IQ, OQ & PQ protocols
  • Quality review & approval of Change Requests (CR’s) related to project validation & other validation activities for the site
  • Perform compliance & technical reviews/approvals of protocols & protocol data
  • Review & approve validation failure investigations & non-conformities utilizing root cause analysis techniques
  • Review & approve specifications, procedures & other required supporting documents to maintain the validated state of equipment & processes & the validation or PSE program
  • Identify process improvements before equipment, systems or processes are placed under change control during validation
  • Lead large scale trending analysis and investigations
  • Makes decisions on quality & compliance issues with little guidance
  • Identifies QA process gaps & recommends strategic solutions to meet those business needs
  • Responsible for coaching and mentoring team/site concerning QMS applications and Quality processes
    • Provide coaching to the Site regarding quality & compliance related activities
    • Review & approve complex Deviations, CRs, SOPs, trend & report data for CAPA, QMRs & APR reports
  • Release Product for commercial distribution

 

Accountabilities

  • New Systems Validations
    • Collaborates, reviews & approves IQ, OQ & PQ protocols for direct impact systems/processes per approved timeframes. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment. Serves as a source of expertise in the group for validating new systems
    • Ensures validation protocols executed are in compliance with local, corporate & regulatory regulations
  • Revalidations
    • Reviews & approves revalidation & PSE activities. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment. Serves as a source of expertise in the group for revalidations
    • Ensures revalidation protocols executed are in compliance with local, corporate & regulatory regulations
  • Investigations
    • Supports and/or leads the closure of investigations per approved timeframes. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment
    • Leads project teams to help identify root causes of failures & implement corrective actions which address & eliminate potential reoccurrence of the failures
  • Protocol Review & Approval
    • Completes assigned protocol review & approvals per approved timeframes accurately & completely
    • Ensures protocols & protocol data reviewed are in compliance with local, corporate & regulatory regulations
  • Validation Procedures & Configuration Item List (CIL)
    • Creates & authors assigned validation procedures & CILs. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment
    • Ensures validation procedures & CILs are in compliance with local, corporate & regulatory regulations
  • Other Procedures/Documents Specifications, Process Descriptions, etc.
    • Completes reviews & approvals as assigned per approved timeframes accurately & completely
    • Ensures procedures/documents reviewed are in compliance with local, corporate & regulatory regulations
    • General review & approval of assigned documents
  • Capital Projects
    • Supports validation activities assigned by overall project manager
    • Maintains safe work environment
    • Operates in alignment with NNWay, demonstrating a Quality & cLEAN Mindset

 

Required Qualifications

  • BA/BS in Engineering, Computer Science, or applicable scientific or technical degree
  • Minimum of seven (7) years of validation or quality related discipline experience in pharmaceutical environment
  • Minimum of one (1) year of project management experience for small to medium sized projects with experience developing project schedules & tracking performance
  • Minimum of two (2) years of demonstrated experience using root-cause analysis techniques to solve problems

 

Desired Qualifications

  • Knowledgeable in the following areas:
    • Expert in quality concepts including technical & compliance review of validation-related documents
    • Expert competence in one or more core validation areas (sterilization, packaging, cleaning, utilities, process or computer validation)
    • Expert in cGMP documentation practices.  Requires a minimum of two (2) years of experience in reviewing GMP documents for compliance purposes for approval of quality documentation
    • Basic computer skills including experience in the use of Microsoft word, Excel, etc.
    • Ability to independently write technical documents without supervision
    • Knowledge of statistical methods
    • Expert knowledge of cGMP documentation practices required
    • Excellent oral & written communication skills
    • Experience in regulatory cGMP regulations
    • Experience in validation test equipment including temperature mapping equipment, Kaye equipment as an example, desired
    • Expert knowledge in being a project team participant & team leader
    • Expert in utilizing appropriate root-cause analysis tools & techniques
  • Demonstrated expertise in planning/organizing, managing execution, checking results, & revising the work plan for complex problems being resolved by cross functional teams

 

Physical & Other Requirements

  • Occasionally moves equipment and/or supplies weighing up to 30 pounds within the facility
  • Constantly operates a computer & other office equipment using hands
  • Able to work in an open office environment with the possibility of frequent distraction
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation
  • Able to adjust schedule to work with colleagues in other international time zones

 

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.