Remote - Senior Lead Auditor - Plainsboro, United States - Novo Nordisk
Description
About the Department
Every day, millions of people rely on the quality and safety of our products. The Novo Nordisk Quality Management System (QMS) enables us to manage quality effectively across NN, and we perform audits to ensure compliance with the QMS and
authority requirements and to ensure effectiveness of the QMS.
The Position
Novo Nordisk Quality Audits is responsible for the implementation and delivery of global cross-functional compliance audit program to ensure that the development programs, Marketing Authorization Holders, functions, processes, and systems for Consumers (and all partners) follow Novo Nordisk standards and Heath Authorities requirements.
The purpose of this role is to lead, support and report independent GCP audits according to Novo Nordisk quality systems, Good Clinical Practice (GCP) and current international and national regulations. Provide GCP related quality guidance and assist in the identification and implementation of quality assurance needs for Global GxP Audit and other Business partners. The audits performed on behalf of Quality Audits include all types across GCP disciplines, including internal and external targets.
Relationships
This position is an individual contributor role reporting to the Associate Director for GLP & GCP Audits in the Americas. This role will interact with other GCP Auditors across Denmark, India & the Americas. Key stakeholders include the VP of GLP & GCP Audits, Domain Experts of GCP, and R&D Quality.
Internal Stakeholders: In Corporate Quality organizational areas / Key stakeholder interaction at SVP level / Development and Research & Early Development / CMR regions / Sourcing responsible and sourcing QAs in the different sourcing organizations in NN globally
Other key stakeholder interactions include: Research and Early Development / Development / Global Regulatory Affairs / Global Safety / Local affiliates / Suppliers used for clinical services
Essential FunctionsThis position covers the following GCP Audits: Investigator site audits, supplier audits, system processes, internal process, for cause, and complex audits. Key responsibilities includes:Plan, lead, conduct, document and report GCP audits according to the requirements specified in the respective Novo Nordisk procedures as well as applicable standards, quality agreements and guidance documents.Ensure appropriate escalations to responsible management in case of critical audit findings and support immediate follow-up measures according to Novo Nordisk requirementsEnsure up-to-date knowledge of external requirements, standards and guidance documents:Participate in internal trainingParticipate in external training courses, conferences, congresses etc.Provide technical guidance's and training on audit activitiesProvide QA oversight and guidance for the development and implementation of SOPsIdentify and communicate compliance trends and signals:Be alert to early compliance trends and signals and act on it to increase business valueCommunicate potential trends and signals to Audit OwnerApply experience and subject matter expertise to plan, initiate, prepare, conduct and report audits considered to be complex or difficult (either as Senior Lead Auditor or in support of peers)Act as subject matter expert within own areas of expertiseMaintain up-to-date knowledge of legislation, guidance and general interpretation from regulatory sources, as well as relevant changes in industry standards and best practicesIdentify trends, opportunities and risksThe Senior Lead Auditor has the authority to conduct and report audits, and to interpret and make decisions independently. The authority includes issue of audit findings and overall rating (of 'compliance' and 'behaviour'), based on the samples selected during the audit.Practice independently according with agreement with managerSubject to alignment and approval from managerEmbrace and drive Quality Audits key behaviorsAct as a role model and mentor colleaguesParticipate or drive Quality Audits projects (as applicable)
Physical Requirements
Approximately 30% overnight travel is required (includes international travel). The incumbent can work remotely anywhere in the United States with reasonable access to an airport.
QualificationsA minimum of 11 years (Bachelor's degree), or an additional 3 years of experience without a Bachelor's degree, or 8 years (Master's degree) of relevant experience within pharmaceutical, biotechnology, or CRO and/or healthcare settingThorough knowledge of the QMS and Pharma business, and demonstrates capability to see the bigger pictureThorough understanding of relevant regulatory requirementsThorough understanding the Novo Nordisk business in a wider and global contextUnderstands the Quality organization and deliverables, and the value chain incl. how decisions/initiatives within own area of responsibility impacts the broader organization/stakeholdersMaster stakeholder managementMaster change managementSenior Lead Auditor process knowledge:Solid knowledge of potential risk of key processExperience from several relevant processesProven subject matter expertSenior Lead Auditor business knowledge:Excellent understanding of business, value chain and pharmaceutical industry
The base compensation range for this position is $180K to $210K. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.
Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
The job posting is anticipated to close on April 19th, 2024. The Company may however extend this time-period, in which case the posting will remain available on our careers website at www.novonordisk-
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 This contact is for accommodation requests only and cannot be used to inquire about the status of applications.