Senior Manager – North America Operations Quality PV Oversight Position Available In Middlesex, New Jersey

Job Description:

About the Department The Clinical, Medical and Regulatory (CMR)department at Novo Nordisk is one of the most diverse andcollaborative groups within the organization. Fromhealth-care-provider interactions and developing and implementingregulatory strategies with the FDA to providing medical educationand collecting data to support efficacy and new productdevelopment, CMR is involved. The one thing that keeps us allmarching to the same beat is our patient-centered focus. At NovoNordisk, you will help patients around the world. As their needsevolve, so does our challenge to find better and more innovativeways to improve their quality of life. We’re changing lives for aliving. Are you ready to make a difference? The Position Developingquality and strategic objectives and strong business understandingof the value chain and customer focus. This role enables andensures compliance against health authority regulations and NovoNordisk requirements in relation to Pharmacovigilance (PV)oversight and deviations management. This role fulfills the PVOversight function in PV deviation management processes, as well asproviding SME-level input from the affiliate perspective whenrequired. This role also provides direct support for continuousimprovement initiatives, locally or globally driven, for thecovered processes. Communicate direction on a range of uniquelycomplex issues in a simple and understandable manner to i.e. teammembers. Relationships Reports to head of NAO Quality PV Oversight.

Maintains positive rapport and working relationships within andacross departments in relationship to business improvementprojects. Interacts closely with Marketing & Patient Solutions andNNI Patient Safety. External relationships include interactionswith NNI vendors involved in the NNI pharmacovigilance process androutine networking through membership in industry association(s).Manage experienced quality representatives and/or contingencyworkers. Essential Functions Deviation ManagementDevelops andserves as Quality Point of Contact for PV Deviation processcovering NNI Patient Safety Acts in the role of DeviationResponsible for NNI PV Deviation process, including the drafting ofa deviation record with robust root cause analysis utilizingStandard Problem Solving (SPS) methods and strong CAPA developmentwithin the NN deviation IT platform Serve as chair of PV DeviationBoard to facilitate the pre-approval review by board members of allNNI Patient Safety deviations to ensure alignment with NNrequirements and external health authority regulations Developscomprehensive, relevant resources (e.g. training program, FAQs) toenable compliance with Deviation process requirements across NNIand global as applicable Develops and executes regularsurveillance, follow-up, and reporting program to ensure processcompliance within the scope of the Center of Excellence (COE)Proactively identifies quality drift in NNI Patient Safety and NNIprocesses to mitigate deviation occurrence Support internal andexternal stakeholders with issue resolutions in a timely fashionand in a manner which meets their expectations Coordinates andcollaborates with Quality Assurance function to maintain a COE fordeviation management covering NNI Provides SME support to employeesworking within the Deviation process, including consultation onin-process change requests within the scope of the COE Develop andleverages relationships with HQ SMEs, process management, andsystem management to influence process and system development in amanner consistent with global affiliate health authority and/orstakeholder requirements Provides support to NAO Quality processesincluding but not limited to internal audits and inspectionsDemonstrate leadership skills via acting as project lead oncross-functional projects in the development and/or implementationof processes and programs System ManagementActs as SME for thecurrent deviation management IT system, with specific focus onDeviation module Participate in relevant governance bodies e.g.

Core Process Groups Physical Requirements Approximately 10%overnight domestic and/or international travel. Development OfPeople Supervisory. Ensure that reporting personnel have individualdevelopment plans (IDP), with annual goals and measurements thatare consistent with the priorities of the business, and thatinterim reviews are held so that their work is focused on thosepriorities, and they understand their level of accountability forresults and the measurement process. Ensure that the IDP formsinclude completed learning and aspiration plans and are in placefor all reporting personnel to enable the achievement of goals andcapability to assume increased levels of responsibility. Manage theapplication and communication of all Novo Nordisk policies,procedures, and Novo Nordisk Way. Qualifications EducationLevelBachelor’s degree required; relevant experience may substitutefor degree, when appropriate; advanced degree preferred ExperienceLevelRequires 8 years of progressively responsible relatedexperience, with at least 4 years in area of specialty (deviationmanagement); pharma experience preferred Specific or technical jobskillsStrong Root Cause Analysis and CAPA development skills. PVexperience/knowledge preferred Excellent interpersonal skills andability to interact with staff across all levels Demonstratedability to work independently without appreciable directionCapability to identify, evaluate, and resolve complex issues thatrequire reviewing multiple factors to determine proper resolution,with management support as needed Demonstrated problem solvingskills, creativity, and initiative Managerial experience (ifapplicable): Experience managing others is a plus The basecompensation range for this position is $170,000 to $200,000. Basecompensation is determined based on a number of factors. Thisposition is also eligible for a company bonus based on individualand company performance. Novo Nordisk offers long-term incentivecompensation and or company vehicles depending on the position’slevel or other company factors. Employees are also eligible toparticipate in Company employee benefit programs including medical,dental and vision coverage; life insurance; disability insurance;401(k) savings plan; flexible spending accounts; employeeassistance program; tuition reimbursement program; and voluntarybenefits such as group legal, critical illness, identity theftprotection, pet insurance and auto/home insurance. The Company alsooffers time off pursuant to its sick time policy, flex-ablevacation policy, and parental leave policy. We commit to aninclusive recruitment process and equality of opportunity for allour job applicants. At Novo Nordisk we recognize that it is nolonger 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 knowthat this is only possible with talented employees with diverseperspectives, backgrounds and cultures. We are therefore committedto creating an inclusive culture that celebrates the diversity ofour employees, the patients we serve and communities we operate in.

Together, we’re life changing. Novo Nordisk is an equal opportunityemployer. Qualified applicants will receive consideration foremployment without regard to race, ethnicity, color, religion, sex,gender identity, sexual orientation, national origin, disability,protected veteran status or any other characteristic protected bylocal, state or federal laws, rules or regulations. If you areinterested in applying to Novo Nordisk and need special assistanceor an accommodation to apply, please call us at 1-855-411-5290.This contact is for accommodation requests only and cannot be usedto inquire about the status of applications.