Jobs at Novo Nordisk
34,827 open positions
Associate Director - Global Regulatory Lead
Company: Novo Nordisk
Location: Princeton-Trenton
Posted Apr 27, 2024
Novo Nordisk is seeking a collaborative and science-driven global regulatory expert for their East Coast Global Development Hub. The role involves leading a global regulatory team, developing and executing regulatory strategies for high impact projects, and interacting with regulatory authorities. The ideal candidate should have a Bachelor's degree, at least 8 years of pharmaceutical industry experience, and demonstrated knowledge of global regulatory requirements. They should also have experience in rare disease drug development, innovative trial design, and expedited regulatory pathways. Excellent communication skills, strong organizational abilities, and the capacity to thrive in a busy environment are required. Novo Nordisk is committed to an inclusive culture and equal opportunity employment.
SAP CMMS Data Analyst - FFEx
Company: Novo Nordisk
Location: Raleigh-Durham, NC
Posted Apr 25, 2024
Novo Nordisk, a global leader in diabetes care, offers life-changing careers with competitive pay, comprehensive benefits, and opportunities for career growth. The company operates three pharmaceutical manufacturing facilities in North Carolina, producing innovative treatments for diabetes and obesity. The role involves serving as a subject matter expert for SAP Computerized Maintenance Management System (CMMS), leading data migration, establishing master data, and driving continuous improvement activities. The ideal candidate should have a Bachelor's degree in engineering, relevant experience, and expertise in SAP MM & PM database structure. Novo Nordisk is committed to diversity and inclusion, offering equal opportunity employment.
LEAN Manufacturing Partner I - FFEx
Company: Novo Nordisk
Location: Raleigh-Durham, NC
Posted Apr 25, 2024
Novo Nordisk, a global leader in diabetes care for over a century, offers life-changing careers with competitive pay, comprehensive benefits, and opportunities for career growth. The company operates three pharmaceutical manufacturing facilities in North Carolina, including the Injectable Finished Products (IFP) facility in Clayton. The role involves enabling and inspiring the NNPILP team to adopt a continuous improvement mindset, driving CI projects, and providing coaching and mentoring. The ideal candidate should have a Bachelor's degree in a relevant field, two years of manufacturing or related industry experience, and demonstrated expertise in Lean tools and Six Sigma Green Belt. Novo Nordisk is committed to diversity, inclusion, and equal opportunity employment.
Director - NACD (North America Clinical Dev) Operations
Company: Novo Nordisk
Location: Miami, FL
Posted Apr 14, 2024
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is a diverse and collaborative group, focusing on patient-centered care. The position involves daily people management, ensuring effective performance, team collaboration, and employee engagement. The role requires leadership in a complex and changing environment, managing clinical trial sites, and establishing relationships with external and internal partners. Essential functions include planning and strategy, analyzing business needs, change management, finance and resource management, performance monitoring, risk management, cross-TA collaboration, and stakeholder management. The ideal candidate should have a Bachelor's degree, advanced degree preferred, and at least 12 years of experience in clinical trials. Expertise in ICH-GCP principles, FDA interactions, and strong communication skills are required. Novo Nordisk is committed to an inclusive culture and equal opportunity employment.
Manufacturing Operator I - Packaging, 2nd Shift
Company: Novo Nordisk
Location: Raleigh-Durham, NC
Posted May 04, 2024
<p><b>About the Department<b> <br >For more than 100 years Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases such as diabetes amp obesity Being part of Novo Nordisk allows our employees to embark on lifechanging careers and the opportunity to help improve the quality of life for millions of people around the world <br >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 194000 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 <br >What we offer you <br ><p><ul><li> Leading pay and annual performance bonus for all positions <li> <li> All employees enjoy generous paid time off including <b>14 paid holidays<b> <li> <li> Health Insurance Dental Insurance Vision Insurance effective day one <li> <li> Guaranteed 8 401K contribution plus individual company match option <li> <li> Family Focused Benefits including 12 weeks paid parental amp 6 weeks paid family medical leave <li> <li> Free access to Novo Nordiskmarketed pharmaceutical products <li> <li> Tuition Assistance <li> <li> Life amp Disability Insurance <li> <li> Employee Referral Awards <li> <ul><p><br >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 <br ><b>The Position<b> <br >Efficiently effectively amp safely clean setup amp operate manufacturing equipment to achieve production goals while adhering to applicable cGMPs amp SOPs <br ><b>Relationships<b> <br >Shift Manager <br ><b>Essential Functions<b> <br ><p><ul><li> Setup operate monitor amp control equipment systems amp processes <li> <li> Clean amp sanitize manufacturing filling amp packaging rooms amp equipment per SOPs <li> <li> Execute production schedule to achieve production goals <li> <li> Handle labeling amp components correctly transferring counting FIFO returns etc <li> <li> Participate actively in amp support event response <li> <li> Review amp author SOPs amp other documents as required <li> <li> Identify report amp resolve quality issues <li> <li> Execute ampor assist during equipment maintenance including restoration of lost function predictive amp preventative maintenance <li> <li> Train fellow employees in areas of expertise amp aggressively learn systems amp equipment outside of own expertise with the appropriate experience amp skill level <li> <li> Recordreview production data in BPR amp associated forms <li> <li> Follow all safety amp environmental requirements in the performance of duties <li> <li> Other accountabilities as assigned <li> <ul><p><br ><b>Physical Requirements<b> <br >Moves equipment ampor supplies weighing up to 33 pounds within the facility Routinely operates amp inspects manufacturing equipment Strap amp unstrap pallets Must be able to be on your feet for up to a 10hour shift May require corrected vision to 2020 or 2025 based on role May require color vision based on role Occasionally ascendsdescends a ladder May be required to work at elevated heights Occasionally works around odorous ampor hazardous materials May be required to wear latex gloves May perform critical job functions in extremely cold work environments depending on site May position oneself within confined spaces for inspection if required of the role Ability to work in loud noise environments with hearing protection May be required to secure a motorized vehicle license amp operate a motorized vehicle based on the role <br ><b>Qualifications<b> <br ><p><ul><li> High School Diploma or GED required <li> <li> Associates degree preferred <li> <li> Minimum of one 1 year of experience in a manufacturing industry preferred or may consider a completed BioWorksBioBlend Certificate military experience or a current contingent worker with three 3 months of demonstrated performance in the rolerelevant area in lieu of work experience <li> <li> FDA regulated industry amp solid dose manufacturing experience preferred <li> <li> Ability to read write amp understand complicated product documentation amp standard operating procedures with attention to detail required <li> <li> Computer literacy including use of Microsoft Office suite programs required <li> <li> Some basic mechanical skills preferred <li> <ul><p><br >We commit to an inclusive recruitment process and equality of opportunity for all our job applicants <br >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 were life changing <br >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 <br >If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply please call us at 18554115290 This contact is for accommodation requests only and cannot be used to inquire about the status of applications<p>
Senior Automation Engineer
Company: Novo Nordisk
Location: Raleigh-Durham, NC
Posted Apr 25, 2024
Novo Nordisk, a global leader in diabetes care, offers a rewarding career opportunity in Clayton, NC. The role involves supporting the design and implementation of automation for process or utility systems, with a focus on improving reliability and meeting customer, business, and regulatory requirements. The ideal candidate should have a BA/BS in engineering or related field, minimum ten years of engineering experience in process-based manufacturing, and expertise in SCADA, PLC, HMI, and Windows-based operating systems. Novo Nordisk is committed to an inclusive culture and equal opportunity employment.
QC Associate (Technical Writing)
Company: Novo Nordisk
Location: Other US Location
Posted May 03, 2024
<p><b>About the Department <b> <br >Site New Hampshire located in West Lebanon is where Novo Nordisks lifesaving 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 cuttingedge medications <br >What we offer you <br ><p><ul><li> Leading pay and annual performance bonus for all positions <li> <li> 36 Paid days off including vacation sick days amp company holidays <li> <li> Health Insurance Dental Insurance Vision Insurance <li> <li> Guaranteed 8 401K contribution plus individual company match option <li> <li> 12 weeks Paid Parental Leave <li> <li> Free access to Novo Nordiskmarketed pharmaceutical products <li> <ul><p><br >At Novo Nordisk you will find opportunities resources and mentorship to grow and build your career Are you ready to realize your potential <br ><b>The Position<b> <br >This position has primary responsibility to support operations for Quality Control at our biologics manufacturing facility Assists in coordination and execution of process and equipment improvement programs creates technical reports reviews completed quality records generates quality comment and deviation responses and has ability to provide training support Prior experience as a Technical Writer or peforming Technical Writing is preferred for this position This role will support our QC teams under the direction of the QC Manager <br ><b>Relationships<b> <br ><p><ul><li> Reports to Quality Control Manager <li> <li> Number of subordinates with directindirect referral no direct reports <li> <ul><p><br ><b>Essential Functions<b> <br ><p><ul><li> Liaison between Manufacturing and QC for the coordination of processequipment improvements sample testing and data trendinganalysis <li> <li> Review of completed QC documentation <li> <li> Ability to assist with training to support on the QC equipmentprocesses <li> <li> Revise documentation SOP forms reports notebooks associated with the testing of inprocessproduct samples requiring some direction <li> <li> Incorporate preplanned process improvements and cost reduction projects into QC <li> <li> Ability to take on multidisciplined projects with minimal supervision <li> <li> Functional understandingapplication of quality systems with the ability to manage Change Controls <li> <li> Support deviation and CAPA investigations and corrective actions <li> <li> Support of Health Authority inspections <li> <li> Support area equipment validations in accordance with procedures requiring some direction <li> <li> Possesses technical and systems knowledge and is able to research information outside of knowledge base <li> <li> Has ability to recognize problems and recommend solutions to problems based on technical understanding of testing techniques <li> <li> Other duties as assigned <li> <li> Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws regulations and industry codes <li> <li> Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others <li> <ul><p><br ><b>Qualifications<b> <br ><p><ul><li> Education and Certifications <ul><li> High School diploma or equivalent with a minimum of six 6 years relevant manufacturing experience or a Bachelors degree or equivalent in a science or engineering discipline with three 3 or more years of experience <li> <ul><li> <li> Knowledge Skills and Abilities <ul><li> Requires functional understanding of cGMPs established manufacturing practices and procedures and compliance with Quality regulations and guidelines <li> <li> Ability to understand and execute established written instructions is essential <li> <ul><li> <ul><p><br ><b>Physical Requirements<b> <br >010 overnight travel required The ability to climb balance kneel reach stand and walk The ability to push pull lift finger feel and grasp The ability to speak listen and understand verbal and written communication Repetition including substantial movement of wrists hands and or fingers Lifting up to 33lbs15kg of force occasionally andor up to 30 pounds of force frequently andor up to 10 pounds of force constantly to move objects The worker is required to function in narrow aisles or passageways 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 including temperature changes proximity to moving mechanical parts moving vehicles electrical current working on scaffolding and high places exposure to high heat or exposure to chemicals <br >We commit to an inclusive recruitment process and equality of opportunity for all our job applicants <br >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 were life changing <br >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 <br >If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply please call us at 18554115290 This contact is for accommodation requests only and cannot be used to inquire about the status of applications<p>
IT Process Analyst
Company: Novo Nordisk
Location: Raleigh-Durham, NC
Posted Apr 14, 2024
Novo Nordisk, a global leader in diabetes care for over a century, offers life-changing careers with competitive pay, comprehensive benefits, and opportunities for career growth. The company operates three pharmaceutical manufacturing facilities in North Carolina, including a 457,000 square foot aseptic 'fill and finish' site in Clayton. The role involves developing and updating IT system incident and downtime tracking models, analyzing production equipment issues, and providing input to improvement projects. The ideal candidate holds a Bachelor's Degree in a technical field, with a minimum of two years of technical experience in operation, design, process improvement, LEAN, or Six Sigma certification. Novo Nordisk is committed to an inclusive culture and equal opportunity employment.
Automation Engineer I
Company: Novo Nordisk
Location: Raleigh-Durham, NC
Posted Apr 14, 2024
Novo Nordisk, a global leader in diabetes care for over a century, offers life-changing careers with competitive pay, comprehensive benefits, and opportunities for career growth. The company operates three pharmaceutical manufacturing facilities in North Carolina, including the Injectable Finished Products (IFP) facility in Clayton, responsible for producing innovative diabetes and obesity treatments. The role involves working with teams and vendors to ensure process control systems align with local and global standards, and supporting plans to maintain and improve these systems. The ideal candidate holds a Bachelor's degree in engineering or a related field, with at least three years of experience in process-based manufacturing, utility, or packaging systems. Novo Nordisk is committed to an inclusive culture, celebrating diversity and providing equal opportunity for all job applicants.
QSMS Documentation Area Specialist II
Company: Novo Nordisk
Location: Raleigh-Durham, NC
Posted Apr 25, 2024
Novo Nordisk, a global leader in diabetes care for over a century, offers life-changing careers with competitive pay, comprehensive benefits, and opportunities for career growth. The company operates three pharmaceutical manufacturing facilities in North Carolina, producing injectable and oral treatments. The role involves supporting document owners in the writing process, ensuring clear and reader-friendly language, and collaborating cross-functionally within the site. The ideal candidate should have an associate's degree in business or technical field, minimum three years of experience in technical writing, and proficiency in MS Word, Adobe Acrobat Pro, Excel, PowerPoint, Visio, and HTML. Novo Nordisk is committed to an inclusive culture and equal opportunity employment.
Director - Medical Affairs CV Renal East
Company: Novo Nordisk
Location: Princeton-Trenton
Posted Apr 13, 2024
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is a diverse and collaborative group, focusing on patient-centered care. The position involves field coaching, mentorship, and management of Medical Liaisons, developing strategies for key healthcare provider relationships, and ensuring compliance with laws and regulations. The role requires strategic planning, management of field medical teams, and coordination with various departments. The ideal candidate should have a doctoral degree, extensive pharmaceutical industry experience, and Medical Liaison experience. Novo Nordisk offers competitive compensation, benefits, and a commitment to diversity and inclusion.
Deviation Leader & Coordinator
Company: Novo Nordisk
Location: Other US Location
Posted May 04, 2024
<p><b>About the Department<b> <br >Site New Hampshire located in West Lebanon is where Novo Nordisks lifesaving 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 cuttingedge medications Its not your average production site its a tightknit supportive community working together to contribute to a better tomorrow for our patients Ethics and quality are held in the highest regard and a patientfocused mindset guides everything we do Were looking for individuals who are selfstarters 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 <br ><b>The Position<b> <br >The Deviation LeaderCoordinator is responsible for the quality and oversight of the deviation investigation and CAPA corrective actions and preventive actions management processes The Deviation Leader is also responsible for fostering a learning culture within the Deviation Investigation organization and working with site leadership to strengthen and support a learning culture across the site This role involves leadership and supervision of the investigation team ensuring deviation investigation approaches are appropriate and suitable to the businesss operations and communicating and escalating deviation priorities risks and impacts to site leadership and other key stakeholders Will also be responsible for leading investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations This position will be responsible for operating crossfunctionally collecting necessary data and information associated with operational deviations and a champion for quality priority principles and compliance within the organization <br >This is an <b>onsite based role <b>with relocation assistance eligible for selected candidate<br ><b>Relationships<b> <br >Reports to Director of MSAT amp Quality Control <br >Number of subordinates with directindirect referral Incumbent will have mix of direct and indirectmatrixed investigators as subordinates <br ><b>Essential Functions<b> <br ><p><ul><li> Assess the current state of deviation investigations and creationassignment of CAPA Identify recurrent deviation types and potentially ineffective CAPA and introduce new investigation techniques andor improve the effectiveness of current investigation techniques <li> <li> Manage site deviation metrics and leading indicators including target ranges for the number of open deviations as well as deviation and deviation action closure times <li> <li> Facilitate weeklydaily management review of deviation metrics Create processes to identify response actions and track accountability for completion of actions <li> <li> Create and deploy process to assess deviations and assign investigation and approval team within one business day of initiation <li> <li> Refine CAPA effectiveness check process to ensure that investigations identify meaningful causes that map to actionable and effective CAPA that reduce recurrent deviation types <li> <li> Lead and supervise the deviation investigation team assign deviations based on investigator skillexperience and deviation type ensure levelloading of investigator workload and identify and support training and development opportunities to advance investigators skillsets Mentor and coach investigators <li> <li> Identify and deploy advanced investigational techniques to support more effective investigations and identification of meaningful causes Examples may include human and organizational performance advanced interview techniques standardized data collection methods branching cause maps and other methods <li> <li> Maintain expertise in deviation investigation best practices through ongoing training and participation in industry associations <li> <li> Collaborate with site leadership to ensure the deviation process is supporting highlevel organizational goals and outcomes <li> <li> Partner with site leadership to identify opportunities to support a learning culture within the organization so that processes are improved and error opportunities are identified and corrected in a predeviation state <li> <li> Lead crossfunctional investigation teams to identify root cause evaluate technical impact and provide recommendations to management on batch disposition <li> <li> Manage and author investigations to meet key timing commitments with wellinvestigated and welldocumented deviation reports <li> <li> Develops a comprehensive understanding of the manufacturing processes and the associated risk management control strategy developed to identify process risks and associated critical controls around the associate processing steps <li> <li> Provide mentorship to deviation management team members <li> <li> Acts proactively to ensure standardized process operations and promote team collaboration <li> <li> Provide followup and scheduling to ensure the batch release process is not impacted by outstanding deviations <li> <li> Ensure investigations will comply with internal NN requirements and are compliant with cGMP regulations <li> <li> Update SOPs or other official documents as required <li> <li> Support other quality compliance and implementation projects as assigned <li> <li> Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws regulations and industry codes <li> <li> Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others <li> <ul><p><br ><b>Physical Requirements<b> <br >Local and international travel up to 10 of the time Prolonged periods of sitting or standing at a desk and working on a computer Must be able to lift up to 15 pounds at times Ability to gowning and work in clean room areas for investigations Offshift work may be required <br ><b>Development of People<b> <br >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 <br >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 <br >Manage the application and communication of all Novo Nordisk policies procedures and Novo Nordisk Way <br ><b>Qualifications<b> <br ><p><ul><li> Education and Certifications <ul><li> BS degree in related engineeringscientific field MS preferred <li> <li> Certification in Six Sigma or other process improvement methodology is preferred <li> <ul><li> <li> Work Experience <ul><li> Minimum 2 years of experience directly leading and supervising <li> <li> Minimum 3 years of experience conducting deviation investigations in a cGMP pharmaceutical manufacturing environment with a Bachelors <li> <li> Minimum 3 years of technical andor investigative writing with demonstrated proficiency in implementing effective CAPAs based on investigation results <li> <li> Minimum 7 years total experience supporting cGMP pharmaceutical manufacturing either in manufacturing or in a direct support role with a Bachelors degree or minimum 5 years experience supporting cGMP pharmaceutical manufacturing either in manufacturing or in a direct support role with a Masters degree <li> <li> Strong understanding of US and international cGMP regulations governing pharmaceutical manufacturing and in the application of such regulations <li> <li> Familiar with Lean Six Sigma methodologies and proven analyticalproblem solving capabilities analysis of complex problems through critical analytical thinking <li> <li> Proficient in the use of problem solving tools A3 5WHY Fishbone diagram Is and IsNot Root Cause Analysis Human Error Reduction <li> <li> Demonstrated ability of meeting goalstimelinesorganizational skills <li> <li> Experience in API Manufacturing preferred <li> <ul><li> <ul><ul><li> Knowledge Skills and Abilities <ul><li> Technical writing experience writing deviations and CAPAs in the pharmaceuticalbiotech industry Experience with deviation or investigation management systems <li> <li> Ability to put complex thoughts and issues into writing in such a manner that an educated but uninformed reader can understand and make decisions based on the written investigation report <li> <li> Experienced in troubleshooting investigation and rootcause analysis in a cGMP environment <li> <li> Ability to evaluate data and make recommendations based on data analysis <li> <li> Must be familiar with health authority FDA requirements <li> <li> Ability to work in a fastpaced environment with the capability to prioritize effectively to meet timelines <li> <li> Facilitation and coaching skills <li> <li> Strong technical writing skills <li> <li> Excellent organizational communication and interpersonal skills and the ability to interact with all levels of management vendors and employees from the shop floor to global leadership <li> <ul><li> <ul><p><br >We commit to an inclusive recruitment process and equality of opportunity for all our job applicants <br >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 were life changing <br >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 <br >If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply please call us at 18554115290 This contact is for accommodation requests only and cannot be used to inquire about the status of applications<p>