About the Department
Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our greater Boston R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients.
The team is comprised of collaborative, diverse and passionate people who have a true sense of pride in their work and are committed to helping others grow and develop their careers. You’ll also have a platform to engage with key stakeholders on a global scale throughout the entire pipeline process. And while changing the future of diabetes, obesity and MASH treatment is no easy task, we also recognize the importance of an enjoyable workplace, which is why we’ve cultivated a culture of fun, ingenuity and innovation. And our competitive compensation package and support of a healthy work-life balance all add to a best-in-class employee experience. Are you ready to make a difference?
The Position
This senior quality role will have overall responsibility for compliance topics within the acquisition sites (Cham, Anagni, Brussels, Bloomington) and will support improvements to the site's compliance profiles, including support during regulatory inspections, ensure sharing of findings between sites and harmonizing with Novo Nordisk approaches. This role will sit on the AMIQA Quality Leadership team.
Relationships
Reports to the CVP of AMI QA.
Key stakeholders: CVP AMIQA Quality, CVP Complaints, Inspections and Audit, Site Quality Heads, Quality and Site Integration Leads and Key management from sites.
To accomplish goals/objectives this job interacts on a regular basis with: Senior management of external/global CDMO customers, CVPs of the Italian, Belgium and US-based acquisition sites, CVP of Quality Excellence and Innovation and Site quality and compliance team members responsible for audits, compliance improvements, procedures and processes.
Essential Functions
-Ensure consistent compliance for Acquisition Sites:
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-Interact with sites to understand areas of compliance risk
-Provide expertise in closing gaps
-Interface with site leadership and corporate leadership to support funding and prioritization of efforts
-Monitor changes in regulations and work to proactively install at the sites
-Establish site collaboration forums to drive harmonization
-Work with internal and external experts to conduct a compliance gap assessment, establish Quality Improvement Plans (QIP) and track progress:
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-Coordinate 3rd party and internal resources to conduct compliance gap assessments
-Review recommendations and develop prioritization
-Work with sites to establish QIP and to track progress
-Prepare progress reports and dashboards as appropriate to ensure visibility to implementation of improvements
-Interface with Novo Nordisk support functions from Audits and Inspections:
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-Work with corporate audit team to manage internal audits
-Build process to track regulatory signals at the acquisition sites
-Participate in SME forums related to quality and compliance
-Interact with CDMO Customers to support overall quality programs
-Member of AMI QA Quality Management Team:
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-Sit on quality leadership team for AMIQA Quality representing compliance
-Establish visual management tools for leadership team to track performance
-Serve as part of the ‘Ringfence” organization with access to sensitive client information
-Support ‘above site’ processes as required through the period of department building
-Access to customer sensitive and confidential information as required and ensure the information is handled confidentially and in accordance with relevant specific policies
-Degree of influence on departmental/function/NN results:
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-Direct influence to the level of compliance at the three (3) sites and indirectly through working in the specific departments
-Influence may Impact NN results in the way that this function has the responsibility to secure the specified quality on delivered goods and services is being met
-Drive initiatives to continuously improve both the quality and compliance in the 3 sites
-Own initiatives on quality and actively participate with the sites to achieve compliance improvements
Physical Requirements
Travel within the US and within Europe must be expected. Frequency of travel will be determined by the on-site presence required to deliver on the area of responsibility, e.g., compliance improvement programs. Majority of governance and leadership meetings will be conducted as virtual meetings. Travel is estimated to vary from 25-50%.
Qualifications
-Bachelor’s degree in Chemistry, Microbiology or related scientific field of study from an accredited university required, with a minimum of eleven (11) years of experience in quality (quality assurance, quality control, and ISO standards required, preferably in a cGMP manufacturing environment
-Knowledge and full understanding of c GMP and all relevant laws and guidelines required
-Documented knowledge and experience with quality assurance, quality systems, quality audits and quality management including cGxP and ISO9000 standards e.g., ISO13485 required
-Experience with authority inspections and process optimization required
-Knowledge and experience from core processes in the biotechnological, pharmaceutical or device industry e.g., research, development, regulatory affairs, and production required
-Solid commercial business and market understanding required
-Cross organizational/cultural understanding required
-Documented international experience with major multicultural assignments preferred
-Management and leadership experience on senior management level preferred
-Must be able to demonstrate a high-level of innovation and initiative to rethink the current way of working to improve compliance profile through a period of company growth and integration
-Ability to demonstrate a structured and analytical approach required
-Ability to work independently as well in a team required
-Ability to work, build relationships and trust on all levels of an organization and in different cultures required
-Ability to work independently and take own initiatives and decisions within own area and for stakeholders on compliance related subjects within assigned responsibility limits required
-Managing the task described above is complex, as these are almost always cross-site/functional in nature, entail working on several organisational levels and involve balancing interests of several stakeholders operating globally across time zones. Decision taking time slot is often limited meaning that high pressure environment is a fact. Consequently, it requires management experience (+15 years) and an ability to handle complex decisions
The base compensation range for this position is $225,000 to $290,000. 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.
The job posting is anticipated to close on September 20, 2025. The Company may however extend this time-period, in which case the posting will remain available on our careers website at
novonordisk-us/careers.
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 , please Apply at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
