Associate Director, Quality Control

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.

Position

Lead strategic activities to drive line performance, process improvements & technical improvements within the assigned department. Ensure fulfillment of departmental targets in accordance with the Novo Nordisk Way while maintaining compliance with applicable regulations & SOPs. Manage all activities & personnel related to the establishment & operation of the laboratories supporting analysis of materials & products for the associated stakeholders.

Essential Functions

• Drive a safe workplace culture, ensuring safety & environmental requirements are met
• Ensure processes are capable of meeting quality specifications & requirements
• Drive alignment to annual P&O processes (Evolve, One Review, Talk-to Grow, etc.)
• Focus on eliminating defects & building simplicity into processes
• Align process activities with lead time targets
• Set direction by developing transparent process objectives based on site goals
• Drive process performance to meet business & customer needs
• Use systems & coach employees to maximize value & minimize waste
• Provide strategic resource planning to operate processes in a cLEAN® way
• Coach, develop and engage direct reports, focusing on the NNWay essentials
• Integrate quality & business ethics into all decisions
• Coordinate with head of department& other teams on workload issues & priorities
• Frequent planning to ensure resources are in place to execute the plan, to include ensuring alignment with all budget/cost, quality and deliverables
• Ensure tracking & reporting of KPIs
• Communicate with customers and stakeholders to ensure knowledge transfer & alignment with all other relevant stakeholders
• Follow all safety and environmental requirements in the performance of duties

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.

Qualifications

• Bachelor's Degree in science, engineering or related field of study from an accredited university required, with a minimum of seven (7) years of direct leadership/management experience in a clinical or industrial/pharmaceutical laboratory and a minimum of eight (8) years working in a manufacturing environment required, preferably a pharmaceutical manufacturing environment
• Minimum five (5) years of analytical GMP laboratory experience required
• Knowledgeable in one or more of the following areas: Microbiological or chemical testing, Laboratory Equipment, Validations/Transfers, Stability programs, GMPs, or laboratory techniques required based on assigned area
• Experience driving process improvements/design using systematic methodologies, Lean principles, Six Sigma, etc., required
• Demonstrated attention to detail, proofreading & strong computer skills with a willingness to learn new IT applications required
• Demonstrated knowledge of US & ISO regulations & guidelines, & applications of cGMP’s within microbial area based on assigned area required
• Demonstrated knowledge of pharmaceutical industry validation requirements including a thorough understanding of cleaning, equipment, utility, computer & process validation requirements & concepts required
• Excellent written & oral communication skills & the ability to author scientific & technical reports required
• Organization/Planning: Proven expertise in leading execution of a process, planning/organizing, checking results & creating the cycle plan in accordance with testing needs required
• Proven expertise in mentoring & staff development, change management, planning & organizing, managing execution & revising work plans for complex issues addressed by cross functional teams required