Senior Manager, FP Process & Compliance

Novo Nordisk • Clayton, NC

2d • Onsite

About The Position

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. 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-by-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.

Requirements

• Bachelor's Degree in Engineering, Science, Business or related field.
• 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

Nice To Haves

• MS preferred or industry equivalent experience preferred

Responsibilities

• 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.
• 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
• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior