Associate Director

3 weeks ago

Lexington, United States Novo Nordisk Full time

**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.

Do you dream of using your solid GCP knowledge, process optimisation skills and quality mind-set in a highly professional and engaged global environment? Can you bring a positive attitude to successfully lead the clinical inspection process while remaining calm under pressure?

Clinical Compliance is one of four sister departments in Clinical Quality (CQ), which is part of R&D Quality in Novo Nordisk. We play a vital role in supporting the drug development process to ensure high quality as well as fit-for-purpose processes. In Novo Nordisk, we have an ambitious drug development program, and we work in a global setting with focus on delivering viable products that make a difference to patients and ultimately benefit society.
In CQC, we support the development organisation and drive many activities such as:

- being Clinical Quality partners to key projects and line of business,
- leading the GCP inspections,
- providing GCP support globally
- taking part in due diligence and integration activities when looking at and acquiring new assets,
- reviewing and approving audit CAPA plans
- performing vendor assessments and trying to impact external clinical requirements and sharing clinical Quality and GCP knowledge to the global organisation.

We also take active part in cross organizational improvement projects and provide general quality & compliance support to our global organization. We are busy and are on an exciting journey bringing quality on top of the agenda throughout the R&D organization - and maybe you are the one to join us on this journey?

**The Position**

This role will provide leadership and guidance to the Global Clinical Organization before, during and after inspections, working with stakeholders across multiple functions. The Associate Director, CQ, R&D Quality
- will also act as the Clinical Quality Line of Business/ key project(s) lead in the Clinical Operations organization, primarily in the East Cost hub, thereby ensuring built-in quality from the start of clinical trials in BGD. Additionally, this role will support the organization in clinical quality and compliance initiatives by participating/leading improvement projects, conduct supplier assessments of clinical vendors, sharing quality and compliance data insights and by focusing and driving process improvement themes.

**Relationships**

This position reports to a Manager in CQC, R&D Quality in the Novo Nordisk headquarters in Denmark, with a local "host" manager at local site.
**The position does not have any direct or indirect reports.**
Interacts with:
Internal Stakeholders - Development management, BGD management, Novo Nordisk Quality, Clinical Development staff worldwide including line management, Development and support functions in all locations (HQ in Denmark, GBS Bangalore in India, Clinical Outsourcing Management, NNI & BGD in North America), CMRs and GCP Audits
External Stakeholders - Health authorities (in particular for inspections), CROs, IEC/IRBs, Data Protection Agencies, Professional networking such as Drug Information Association, relevant Trade Associations and GCP societies globally

**Essential Functions**
- Clinical Quality Partner
- Quality Partner to Line of Business/key project(s) in the Clinical Operations organization (primarily BGD). Ensure ‘built-in quality from the start of clinical trials in BGD e.g. as ad-hoc member of trial squad, early involvement in vendor selection, protocol development etc.
- Provide GCP Advice and support to the organization
- Deploy quality and compliance data insights in support to projects/stakeholders
- Responsible for leveraging and enhancing GCP, Device and IT understanding
- Participate in relevant working groups on GCP issues and provide support and advice to the organisation regarding quality issues
- Clinical Inspections
- Lead sponsor inspections and preapproval site inspections
- Ensure coordination of all GCP inspections globally
- Drive the global GCP inspection process from notification through to implementation of commitments to authorities
- Participating in sponsor inspections with Health Authorities globally, follow-up, trending, and reporting
- Drive the global cross-functional in

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