Description

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 healthcare 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

The Patient Safety, Compliance & GxP Operational Excellence Lead is responsible for driving efficiency, quality, and innovation across US Quality, GxP Compliance Training and Patient Safety Operations. This role ensures that Safety/Quality/Training processes, systems, and resources are optimized to support regulatory compliance while enabling scalability, automation, and continuous improvement.

Relationships

Reports to the Executive Director, PS & GxP Business Operations. Accountable for establishing and managing relationships with local and global key stakeholders. May have direct reports or indirect reports.

Essential Functions

Operational Excellence & Process ImprovementLead initiatives to streamline Safety/Quality/Training processesApply Lean Six Sigma or other methodologies to eliminate inefficiencies and improve throughputDrive harmonization of workflows across affiliates, partners, and vendorsPerformance Monitoring & InsightsDefine and monitor Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs) for Safety/Quality/Training operationsDevelop and maintain performance dashboards for leadership visibilityProvide insights and recommendations for proactive risk mitigation and capacity planning and allocations across internal and external resourcesTechnology & InnovationPartner with appropriate departments to assist with the implementation and optimization of safety/quality/training systemsDrive adoption of digital tools (AI-assisted case processing, NLP, automation, analytics platforms)Support system change control, validation, and upgrade activitiesGovernance & Change ManagementSupport Safety/Quality/Training leadership in operational and governance meetingsLead cross-functional improvement projects with stakeholders from Quality, Regulatory Affairs, IT, and Global UnitsManage change initiatives to ensure successful adoption across global teamsContinuous Improvement & ComplianceCollaborate with Quality to address recurring CAPAs through process redesign and sustainable solutionsConduct root cause analyses for deviations or performance issuesPromote a culture of continuous improvement and operational excellence

Physical Requirements

0-10% overnight travel required.

Development of People

Supervisory. Train, mentor, and guide direct or indirect team members to enhance their skills and competencies.

Qualifications

Bachelor’s degree required with a focus in Finance, Business Administration, or similarAdvanced degree preferred (MBA or other relevant advanced degree)A minimum of 10 years’ experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting, with at least 5 of those working in or supporting a clinical, medical and/or regulatory organization, in the pharmaceutical industry (Pharma/Biotech/CRO)Experience in leading teams (local required, global preferred)Strong decision-making skills through demonstrated ability to leverage existing or forecasted data into strategy development, resource models, and optimization of plans for the organizationAbility to work independently or within teams in a global and agile environment; strong organization skills; able to streamline and simplify complex concepts for larger audiencesDemonstrated ability to identify risks and opportunities as they relate to resourcing strategiesDemonstrated analytical skills and critical thinking to resolve issues in a variety of complex situations requiring new solutionsExcellent written and verbal communication skills and the ability to be clear and concise in a variety of communication settingsDemonstrated ability to collaborate with local and global stakeholders to design and execute analyses to support decision-making and planningExcellent skills in designing and implementing innovation/improvement initiatives, including change managementAdvanced capability in MS Excel, MS PowerPoint and MS Word required

The base compensation range for this position is $181,670 to $317,920. 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.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.

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.