Immediately Require Senior Manager - GCP Lead Auditor (remote) in Plainsboro, NJ

Job title: Senior Manager - GCP Lead Auditor (remote)

Company: Novo Nordisk

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Senior Manager - GCP Lead Auditor (remote)



Facility: Quality



Location:



Plainsboro, NJ, US



About the Department



The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a difference?



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 Director for GLP & GCP Audits in Denmark. This role will interact with other GCP Auditors across Denmark, India & the US. Key stakeholders include the VP of GLP & GCP Audits, Domain Experts of GCP, and R&D Quality.



Other key stakeholder interactions include: Research and Early Development, Development, Global Regulatory Affairs, Global Safety, Local affiliates & Suppliers used for clinical services.



Essential Functions

• This position covers the following GCP Audits: Investigator site audits, supplier audits, system processes and internal process 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 requirements


• Ensure up-to-date knowledge of external requirements, standards, and guidance documents:

• Participate in internal training


• Participate in external training courses, conferences, congresses etc.


• Provide technical guidance's and training on audit activities


• Provide QA oversight and guidance for the development and implementation of SOPs

• Identify and communicate compliance trends and signals:

• Be alert to early compliance trends and signals and act on it to increase business value


• Communicate potential trends and signals to Audit Owner

Physical Requirements



Approximately 30% overnight travel is required (includes international travel). Valid passport and driver's license is required. The incumbent can work remotely from anywhere in the US



Qualifications

• A Bachelor's degree is required (scientific discipline is preferred). Master's degree or equivalent preferred


• A minimum of 8 years (Bachelor's degree) or 5 years (Master's degree) of relevant experience within pharmaceutical, biotechnology, or CRO and/or healthcare setting


• Lead Auditor experience:

• Ability to manage and objectively evaluate compliance issues


• Extensive knowledge in the framework of GCP including computerized systems


• Experience from clinical trial procedures and partly pharmacovigilance within the clinical area


• Preferably experience with Heath Authority inspections or interaction


• Experience of both remote audits and on-site audits


• Experience of travelling and working internationally

• Lead Auditor business knowledge:

• Good understanding of the business, value chain and pharmaceutical industry


• General experience:

• Thorough knowledge of/experience with Quality and Quality Management systems


• Thorough understanding of relevant regulatory requirements within GCP


• Good quality and compliance leadership and facilitation skills


• Excellent verbal and written communication in English


• Organization and interpersonal skills


• Ability to address a variety of tasks within the same timeframe while maintaining oversight


• Maintain a moderate degree of independence with respect to decision making and problem solving


• Enjoy working independently and lead yourself and others


• Strong stakeholder management skills


• Strong change management skills

In compliance with Colorado's Equal Pay for Equal Work Act, see compensation and benefits below:



The base compensation range for this position is $140 to $170K. Base compensation is determined based on a number of factors. In addition, this position is part of the Annual Performance Incentive Plan. The role may also be eligible for a long-term incentive bonus depending on level and 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 uncapped sick time policy, flex-able vacation policy, and parental leave policy.



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.



Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.



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.

Expected salary: $140000 - 170000 per year

Location: Plainsboro, NJ

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