Senior Project QA Leader – Global Quality & Compliance

Novo Nordisk; Clayton (NC); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

8% 401K contribution with companymatch

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

14 paid holidays

Job summary

Novo Nordisk seeks a proven leader to head the Project QA organization, ensuring compliance with the Novo Way and applicable regulations. You will guide performance management, plan priorities, and drive collaboration with internal and external stakeholders across global sites.

The role emphasizes developing talent, maintaining strong quality systems, and leading continuous improvement initiatives while participating in regulatory inspections and audits to meet business goals.

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 required
• Demonstrated knowledge of pharmaceutical quality systems (i.e., ICH Q10) preferred
• Excellent written & oral communication skills required
• Exercises excellent judgment in decision-making required
• CQA, CMQ/OE, &/or CQE certification preferred
• Project management skills 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

Responsibilities

• 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

Skills

Leadership

Project management

Quality systems

Regulatory knowledge

Communication skills

Mentoring & development

Education

Bachelor's Degree in Life Sciences/Engineering

Tools

LEAN methodologies

Job description

Novo Nordisk seeks a proven leader to head the Project QA organization, ensuring compliance with the Novo Way and applicable regulations. You will guide performance management, plan priorities, and drive collaboration with internal and external stakeholders across global sites.

The role emphasizes developing talent, maintaining strong quality systems, and leading continuous improvement initiatives while participating in regulatory inspections and audits to meet business goals.