Project Director, Quality Assurance - DPM Expansions

Novo Nordisk A/S; Powhatan (NC); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Leading pay and annual bonus

14 paid holidays

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Parental & family leave

Product access

Life & Disability Insurance

Job summary

Novo Nordisk A/S in Clayton, NC, US seeks a Project Director, Quality Assurance to lead the Project QA organization, ensuring compliance with regulations and Novo Way. You will drive delivery of QA commitments across FFEx expansions and partner with Senior Director, Quality.

The role emphasizes leadership of cross-functional teams, regulatory readiness, continuous improvement, and strategic planning to support aseptic manufacturing scale-up and product quality excellence.

Qualifications

• Bachelor's degree in life sciences, engineering or related field.
• Minimum of five years direct management experience leading project teams.
• Minimum of ten years in manufacturing projects within pharma.
• Experience with isolator technology and parenteral production preferred.
• Knowledge of US/EU regs and GMPs; CQE/CMQ/OE certifications preferred.

Responsibilities

• Lead the Project QA team ensuring Novo Way compliance and deliverables.
• Ensure adherence to applicable regulations and procedures.
• Participate in strategy and quality leadership activities.
• Provide performance management and planning of work tasks.
• Foster collaboration with internal and external stakeholders.
• Develop employees and drive high performance and engagement.
• Support regulatory inspections and internal audits as needed.
• Ensure processes meet quality, regulatory and business goals.

Skills

Leadership

Quality Management

Regulatory Knowledge

Project Management

Mentoring

Cross-functional teamwork

Education

Bachelor's Degree in Life Sciences, Engineering

Tools

Isolator tech

Parenteral production

GMP systems

Job description

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Project Director, Quality Assurance - DPM Expansions

Facility: Project Management & Agile

Location: Clayton, NC, US

About the Department

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.

FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

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
• Life & Disability Insurance

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

Responsible for leading the Project QA organization to ensure fulfilment of project deliverables in accordance with the Novo Way while ensuring compliance with applicable regulations & the Novo Quality Management System.

Relationships

Reports to Senior Director, Quality.

Essential Functions

• Responsible for leading the Project QA team in accordance with the Novo Way
• Ensure compliance with applicable regulations & procedures
• Work within the frame of the Novo Quality Mission
• Provide performance management & leader standard work including setting short & long-term objectives & daily detailed planning & prioritization of work tasks
• Promote positive & effective collaboration with internal & external stakeholders
• Develop employees, to include driving high-performance behaviour & creating an environment for positive employee engagement
• Actively participate in Quality Leadership Team and Project Leadership Team activities, including strategy planning for the organization
• Ensure robust processes are in place to meet or exceed quality and business goals, project deliverables, organizational objectives & internal and external requirements
• Champion Continuous Improvement initiatives in the team
• Participate in regulatory inspections & internal audits as necessary
• Follow all safety & 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

• Bachelor's Degree in Life Sciences, Engineering, or related field from an accredited university required
• Minimum of five (5) years direct management experience required, preferably with experience leading high performing project teams. Minimum of five (5) years managing other managers preferred
• Minimum of ten (10) years of experience in a manufacturing organization managing projects, project teams or complex multi-level organizations required, preferably in a pharmaceutical manufacturing industry environment
• Experience with isolator technology & production of parenteral products preferred
• Demonstrated expertise & knowledge of US & EU regulations & guidelines, & application of GMP’s requiredDemonstrated knowledge of pharmaceutical quality systems (i.e., ICH Q10) preferred
• CQA, CMQ/OE, &/or CQE certification preferred
• Demonstrated knowledge of cLEAN® preferred
• Proven expertise in mentoring & development, change management, planning & organizing, managing execution, & revising work plans for complex issues addressed by cross-functional teams required
• Ability to build strong working relationships within the team, with other departments & across other NN sites required

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

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've 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 what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're 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.