Project Manager, QA & QMS - OFP

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. 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 NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies - Oral Finished Products facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. OFP maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

 

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 12 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

Builds & implements quality processes in compliance with cross-functional requirements, as well as regulatory requirements, in a diverse project landscape with a diverse QA & QMS culture to support OFP DU. Ensures that local quality processes are clearly described in a LEAN way. Works closely with quality process stakeholders locally & globally, to ensure that the QA & QMS functions are anchored & followed throughout the project.

This position is a Monday - Thursday role with the hours of 6:00 am - 4:30pm.  Hybrid schedule is available. 

 

Relationships

Manager, QA Support & QMS  – OFP

 

Essential Functions

• Build & implement QA & QMS in a project environment
• Formulates continuous improvement tools for QMS (Quality Management System) operations using LEAN tools & methods constantly supporting the increased maturity of the project
• Ensure site compliance with Regulations, ISO standards, & corporate & local SOPs aligned with project maturity
• Coordinate & support business needs during audits & inspections
• Identify opportunities & turn them into projects for execution
• Ensure projects are completed with metrics & timelines realized
• Develop & implement QA_QMS process improvements for use by Senior Leadership team & process
• Provide training to the Quality Unit & Site regarding quality-related activities
• Performs plant-wide training on Regulations, Quality systems & procedures
• Evaluates trend & report data for QMRs, APRs & other Quality-reports & metrics
• Assists with regulatory-related activities as required
• CAPA Monitoring Responsible, if needed
• Plan & Performs self-audits
• Has product release authority, if needed
• Local Records Manager for records management process, if needed
• Mentors junior QA specialists, interns and co-op students
• Facilitates sharing of regulatory & compliance expectations
• Leads large scope tasks that demand project teams & compliance resource management skills
• Subject Matter Expert (SME) for various Quality Management processes in audits and inspections
• Ensure alignment with global programs & other site projects to actively share best practice, knowledge, & visions
• 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 internationally up to 10% of the time. (% can change on a case-by-case basis based on the role).

 

Qualifications

• Bachelor’s degree in life sciences, engineering or related field from an accredited university is required
• A minimum of six (6) years of project management experience required            
• A minimum of five (5) years of Quality Assurance and/or related experience in the pharmaceutical or medical de