Address
Form of workAbout the Department
Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We’re looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?
The Position
This position manages oversight for activities in the Quality Control Laboratory of NNUSBPI including Analytical Chemistry Testing, BioAnalytical Testing, Microbiology Testing (including oversight of product testing and environmental monitoring programs) and oversight of Quality Inspection functions that may include packaging, returned goods inspection and raw material inspection. Job responsibilities also include maintaining compliance with cGMP and other relevant regulatory requirements. This position interacts with internal customers that include staff representing Manufacturing, MSAT, Facilities & EH&S, Quality Assurance and Materials and Procurement etc.
Relationships
According to the organizational chart. See organizational chart.
Essential Functions
- Provides guidance to employees according to established policies and management guidance. Administers company policies that directly affect subordinate employees. Recommends changes to unit or sub-unit policies
- Provides immediate supervision or assigns tasks to a unit or group of employees. Responsible for the reviews of direct reports with the input from senior management. May provide general or direct supervision to exempt employees and/or skilled nonexempt employees. A portion of the time may be spent performing individual tasks
- Duties include but are not limited to:
- Reviews assay data for accuracy as well as compliance to specifications and reports abnormalities such as statistically relevant trends when needed
- Prepares certificates of analysis for intermediates and products
- Reviews trending data and reports summarizing the trends
- Oversees the scheduling of laboratory work in support of commercial, clinical and/or pre-clinical programs as needed
- Supervises laboratory activities in areas of analytical chemistry and biochemistry testing, bio-analytical testing, microbiology and inspection
- Investigates and resolves issues related assay failures, system deficiencies, deviations, and equipment / assay troubleshooting. Also supervises OOS investigations Oversees CAPA-related activities in areas under management
- Responsible for initiation of document reviews, periodic reviews and documentation revisions as needed
- Provide oversight, guidance and timely and accurate closure for CCAs, CAPAs, deviations, investigations and audit findings
- Oversee warehouse and inspection activities from a Quality perspective, includes inspection of raw materials, intermediates, final product, and packages finished goods.
- Responsible for maintaining line of sight with other QC departments across the company
- Foster an environment of process improvement and resource efficiency
Physical Requirements
0-10% overnight travel required. Travel: 0 - 10%, inside and outside of the US. Must be able to acquire all required documentation. The ability to stoop, kneel, crouch, reach, stand, and walk. The ability to grasp and finger. The ability to speak, listen, and understand verbal and written communication. Repetition including substantial movement of wrists, hands, and or fingers. While performing this job employee work involves sitting most of the time with walking and standing required only occasionally. Lifting up to 10 pounds of force occasionally. Visual acuity to perform close activities such as: reading, writing, and analyzing; and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations. The working environment includes a variety of physical conditions including: noise, inside and outside conditions, working in narrow aisles, and temperature changes;atmospheric conditions including: odors, fumes, and dust.
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
- Education and Certifications:
- Bachelor’s degree or Master’s degree or equivalent experience in Biology, Biochemistry, Chemistry or related field
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.
