Senior Manager, FP Process & Compliance (Clayton, NC, US)

Biopharma Careers; Iowa (LA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K plan

Paid time off

Tuition Assistance

Life & Disability Insurance

Job summary

Novo Nordisk in Clayton, NC seeks an experienced leader to drive tactical and strategic improvements in finished production quality and process robustness. You will mentor teams, develop long-term improvement plans, and uphold robust quality standards across shift operations.

The role emphasizes ownership of quality events, continuous improvement, and collaboration with global manufacturing to ensure compliant, efficient manufacturing of injectable and oral therapies.

Qualifications

• Bachelor's degree in engineering, science, business or related field; MS preferred or industry experience
• 5-7 years leadership/management experience in Manufacturing or Quality; pharma preferred
• Knowledge of packaging and device assembly processes and systems (SAP, Pas-X, Serialization) preferred
• Knowledgeable in Quality Management System, Lean and/or Six Sigma methodologies preferred
• Proven track record of sustainable process improvements and ability to plan, organize, execute and review

Responsibilities

• Lead tactical and long-term strategic activities to improve process and quality within Finished Production
• Coach and develop direct reports with IDPs and annual goals
• Develop long-term process and quality improvement plans
• Champion simple, robust Quality standards and expectations
• Drive quality process performance to meet business and customer needs
• Own coordination of FP APR, customer complaint handling and related processes
• Coordinate with PS@SAP, Pas-X, and Serialization; define roles for these systems
• Monitor and drive corrective actions and audit readiness across the site

Skills

Leadership

Quality mindset

Process improvement

Project management

Mentoring

Education

Bachelor's Degree in Engineering/Science/Business

MS preferred

Tools

SAP

Pas-X

Serialization

Job description

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you’ll join a global network of manufacturing professionals who are passionate about what they do.

What we offer you:

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

The Position

Lead tactical and long-term strategic activities to drive process and compliance improvement within FP and ensure process and quality robustness and standardization across shift teams.

Relationships

Reports to Director, Finished Production.

Essential Functions

• Coaching and mentoring of direct reports in accordance with the NNWay essentials
• 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 the 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 (non-Technical) representing the Clayton site and contributing globally to better / best practices and projects for manufacturing compliance and robustness
• Audit team coordination and development of audit standards / practices
• Ownership of FP APR coordination
• Ownership of FP Customer complaint coordination
• Ownership of procedural support for PS@SAP, Pas-X, and Serialization. Establishment of departmental roles and responsibilities for these systems
• Other accountabilities as assigned

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case‑case basis based on the role.)

Development of People

Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

Qualifications

• Bachelor's Degree in Engineering, Science, Business or related field. MS preferred or industry equivalent experience preferred
• Minimum 5-7 yrs. leadership / management experience in Manufacturing or Quality with a preference toward pharmaceutical or other related industries preferred
• In depth knowledge of packaging and device assembly processes and supporting systems (SAP, Pas-X, Serialization) preferred
• Knowledgeable in Quality Management System, Lean and / or Six Sigma methodologies preferred
• Proven track record of implementing sustainable process improvements preferred
• Proven expertise in planning / organizing, managing execution, checking results, and revising strategic plans to ensure short and long term objectives are met preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.