Associate Director - Clinical Quality job in Lexington
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Massachusetts (MA),
Lexington
Job Code: | 303466-en_US |
Employer: | Novo Nordisk Inc. |
Category: | Biology |
Job Type: | Full Time |
Location | |
Country: | United States |
State: | Massachusetts (MA) |
City: | Lexington |
Post Date: | 05/07/2024 |
Description | |
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? Then you could be a member of our team and serve as an Associate Directors for Clinical Compliance, Research & Development (R&D) Quality. This role will work out of our Lexington, MA location. Apply now for this exciting job opportunity! 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:
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
Physical Requirements The position is located in the Lexington office in BGD. Presence in the office is expected 3 days a week. International and domestic travel should be expected to support inspections and to take part in relevant meetings in Denmark. Up to 30 days a year. Qualifications
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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications. |
ref: (303466-en_US) 12 days ago
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