Project QA Leader - Quality Assurance Strategy

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

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.