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 457000 square foot aseptic fill and finish site that is responsible for producing innovative injectable diabetes and obesity treatments. At PS AM youll 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 14weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

At Novo Nordisk you will find opportunities resources and mentorship to help grow and build your career. Are you ready to realize your potential Join Team Novo Nordisk and help us make what matters.

The 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.

Relationships

Reports to Vice President.

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
• Drive operations standardization equipment maintenance & compliance & collaboration across teams/departments for alignment
• 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
• 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.

Qualifications

• Bachelors 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 cGMPs 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

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

At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve 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 whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were 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-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.