Project QA Director – Aseptic Pharmaceutical Manufacturing

Novo Nordisk A/S; Clayton (NC); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Performance bonus

14 paid holidays

Health, dental and vision insurance –

401(k) with company match

Job summary

Novo Nordisk in Clayton, NC, is seeking a Project Director, Quality Assurance to lead the Project QA organization and ensure compliance with regulatory expectations. The role reports to the Senior Director and emphasizes strategic planning, talent development, and cross-functional leadership to deliver high-quality aseptic manufacturing expansions.

This position offers strong compensation, comprehensive benefits, and opportunities to influence Novo Nordisk's quality systems and continuous

Qualifications

• Bachelor's Degree in Life Sciences, Engineering, or related field from an accredited university required.
• Minimum of five (5) years direct management experience; preferably with experience leading high performing project teams.
• 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 (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.

Responsibilities

• Lead 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

Mentoring

Cross-functional collaboration

Process improvement

Regulatory knowledge

Change management

Strategic planning

Project planning

Education

Bachelor's Degree in Life Sciences, Engineering, or related field

CQA, CMQ/OE, CQE certification (preferred)

Tools

Lean

Job description

Novo Nordisk in Clayton, NC, is seeking a Project Director, Quality Assurance to lead the Project QA organization and ensure compliance with regulatory expectations. The role reports to the Senior Director and emphasizes strategic planning, talent development, and cross-functional leadership to deliver high-quality aseptic manufacturing expansions.

This position offers strong compensation, comprehensive benefits, and opportunities to influence Novo Nordisk's quality systems and continuous