About the Department

　　For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and 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 Emerging Technologies - Oral Finished Products facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. OFP maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

　　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 12 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

　　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

　　Manage all project activities & personnel related to the procurement, qualification, implementation & maintenance of processes, equipment & utilities for the Site. Provide comprehensive validation subject matter expertise. Establish & maintain good communication & working relationship with stakeholders. Meet or exceed customer, business & regulatory requirements in accordance with the Novo Nordisk Way.

　　Relationships

　　Senior Manager.

　　Essential Functions

　　Maintain plans to meet changes in customer requirements

　　Implement projects & evolve the science and risk-based validation program for the Site in accordance with NN procedures & local requirements

　　Develop Site processes and lifecycle management in accordance with NN procedures & local requirements

　　Champion for GMP compliance to ensure 21 CFR part 11 compliance of all computer systems

　　Empower team to successfully execute projects & deliver during the verification process

　　Build and develop a strong high performing cross-functional team

　　Develop relationships with Novo Nordisk project organization & validation project contributors (local & abroad)

　　Collaborate with Site Leadership on workload solutions & advocate for project and resource prioritization

　　Frequent planning to ensure resources are in place to execute according to plan

　　Ensure tracking & reporting of KPI’s

　　Ensure clear and essential communication with customers, ensure alignment with ET OFP DK & all other relevant stakeholders

　　Responsible for ensuring department documents are current & standardized

　　Define user requirements & ensure correct & clear validation & verification activities

　　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

　　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, chemistry, biological sciences, or related field of study from an accredited university required

　　Master’s degree in pharmaceutical, engineering, or other technical science field or equivalent combination of education & experience preferred

　　Minimum three (3) years of process systems support experience, supporting at least one of the following areas required: computerized systems (according to GAMP5, 21CFR11), manufacturing, packaging or warehousing equipment and process verification required

　　Minimum of three (3) years of leadership experience required

　　Understanding of lean project execution principles, continuous improvements & application in a small & large-scale project environment preferred

　　Experienced in the development, implementation, validation &/or maintenance of equipment & facilities in the pharmaceutical/medical device manufacturing, laboratory, or business environment

　　Proven experience with quality systems required

　　Knowledge of Novo Nordisk science & risk-based validation procedures a plus

　　Demonstrated knowledge of pharmaceutical industry validation requirements including a thorough understanding of cleaning, equipment, utility, computer & process validation requirements & concepts required

　　Must demonstrate attention to detail, proofreading & strong computer skills with a willingness to learn new IT application required

　　Demonstrated knowledge of US & ISO regulations & guidelines, & applications of cGMP’s within the raw material area preferred

　　Excellent written & oral communication skills & the ability to author scientific & technical reports

　　Proven expertise in project management, in planning/organization, & project execution required

　　Proven expertise in leading validation & the links to project execution planning required

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

　　At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

　　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.