FP Process & Compliance Senior Manager – Manufacturing

BioSpace; Clayton (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Leading pay and annual bonus

14 paid holidays

Health Insurance, Dental Insurance, V*

8% 401K contribution with companymatch

Parental & family leave

Product samples access

Tuition assistance

Life & Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk in Clayton, NC seeks a senior leader to drive process and quality improvements within Finished Production, ensuring robustness and standardization across shift teams.

Reporting to the Director, Finished Production, you will coach staff, develop long-term quality plans, and coordinate quality event communications. You will oversee PS@SAP, Pas-X, and Serialization and support compliance initiatives; travel up to 10%.

Qualifications

• Bachelor's Degree in Engineering, Science, or related field; MS preferred.
• 5–7 years leadership/management in Manufacturing or Quality; pharma preferred.
• Knowledge of packaging and device assembly; SAP, Pas-X, Serialization preferred.
• Quality Management System, Lean and Six Sigma knowledge preferred.
• Proven track record implementing sustainable process improvements.
• Strong planning, execution, and strategic revision capabilities.

Responsibilities

• Coaching and mentoring of direct reports per NNWay.
• Development of long-term process and quality improvement plans.
• Champion creation of simple and 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 proactively to drive and prioritize compliance improvement projects and initiatives.
• Drive departmental Quality Steering Group agendas.
• Process Group responsibilities representing the Clayton site and global best practices.
• Audit team coordination and development of audit standards/practices.
• Ownership of FP APR coordination and FP Customer complaint coordination.
• Ownership of PS@SAP, Pas-X, and Serialization; establishment of department roles.
• Other accountabilities as assigned.

Skills

Leadership

Quality improvement

Process standardization

Compliance

Audit coordination

SAP

Pas-X

Serialization

Education

Bachelor's Degree in Engineering/Science/Business

MS preferred

Tools

SAP

Pas-X

Serialization

Job description

Novo Nordisk in Clayton, NC seeks a senior leader to drive process and quality improvements within Finished Production, ensuring robustness and standardization across shift teams.

Reporting to the Director, Finished Production, you will coach staff, develop long-term quality plans, and coordinate quality event communications. You will oversee PS@SAP, Pas-X, and Serialization and support compliance initiatives; travel up to 10%.