Senior FP Process & Compliance Leader

Initial Therapeutics, Inc.; Clayton (NC); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Leading pay and annual performance bon

14 paid holidays

Health Insurance, Dental Insurance, Vi

Guaranteed 8% 401K contribution +

14 weeks parental & 6 weeks family lea

Free access to Novo Nordisk products

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk in Clayton, NC, seeks a leader to drive process and compliance improvements within Finished Production, ensuring robust quality standards across shift teams.

Reporting to the Director, Finished Production, this role guides coaching, strategic planning, and cross-functional collaboration to meet business and patient needs, while advancing quality systems and continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Science, or Business; MS preferred.
• 5-7 yrs leadership/management experience in Manufacturing or Quality, pharma preferred
• Knowledge of packaging and device assembly processes and supporting systems (SAP, Pas-X, Serialization) preferred
• Quality Management System, Lean and Six Sigma knowledge preferred
• Proven track record of sustainable process improvements
• Planning/organizing, managing execution, checking results, and revising strategic plans experience preferred

Responsibilities

• Coaching and mentoring of direct reports per NNWay essentials
• Development of long term process and quality improvement plans
• Champion simple, robust Quality standards and expectations
• Drive quality process performance to meet business and customer needs
• Championing Quality Event Communication and Containment processes
• Process confirmation and continuous improvement of NC Process within FP and compliance standards
• Identify trends to drive and prioritize compliance improvement projects
• Drive departmental Quality Steering Group agendas
• Represent Clayton site in Process Group activities and contribute globally to best practices
• Audit team coordination and development of audit standards/practices
• Ownership of FP APR coordination
• Ownership of FP Customer complaint coordination
• Procedural support for PS@SAP, Pas-X, and Serialization; delineation of roles and responsibilities

Skills

Leadership/management

Quality improvement

Quality standards

Compliance

Process optimization

Project planning

Education

Bachelor's Degree in Engineering, Science, or Business

MS preferred or industry experience

Tools

SAP

Pas-X

Serialization

Job description

Novo Nordisk in Clayton, NC, seeks a leader to drive process and compliance improvements within Finished Production, ensuring robust quality standards across shift teams.

Reporting to the Director, Finished Production, this role guides coaching, strategic planning, and cross-functional collaboration to meet business and patient needs, while advancing quality systems and continuous improvement.