Quality Systems Specialist
2 months ago
Do you want to use your skills to make good decisions, ensure regulatory compliance and validation within Novo Nordisk? Are you always looking for continued improvements by challenging the status quo? If so, we now have an open position as Quality System Specialist in our digital validation system team, the TIMS Center of Excellence (CoE).
Join us and apply today
The position
The digital validation system, called TIMS (Technical Information Management System), is based on ALM 12.5 and our team provides support to the validation process, the system owner and validation projects across Novo Nordisk, including guides, procedures, instructions, and training.
As a Quality Systems Specialist and TIMS system architect you will be responsible for specifying and designing the best possible solution for digital validation and ensuring business and quality requirements. Other responsibilities include:
Support Process Expert for validation, Process Owner and Process Owner Delegate in managing the validation process with regards to digital validation. Support NNQ management in improving the process of digitalization. Ensure that current and new regulatory requirements are covered by the process. Collaborate with key stakeholders in the line of business (LoB), QA, system group, and suppliers. Manage and drive maintenance activities within the process in close collaboration with the IT System Manager.Qualifications
We are seeking a Quality Systems Specialist with a strong quality mindset and experience with cross functional use of digital validation.
To succeed in this role, you have:
With your good cooperation and communication skills you can organize and drive tasks. You have a pragmatic approach to problem solving and strong interpersonal skills. You are detail-oriented with a strong quality mindset and are a team player but are also able to work independently. You thrive on working across departments in an international organization. Great communication skills are a must.
We are looking for a person who is team-oriented, self-driven, proactive, and responsible. The ideal candidate excels at collaborating and communicating, is solution-oriented, and demonstrates a strong commitment to actively cultivating a positive working environment.
About the department
The TIMS CoE is part of Investment Portfolio Quality Assurance, an area comprising around 250 highly skilled quality professionals who work to ensure early involvement in production facility investment projects, within the scope of the NN Investment Portfolio Committee.
The primary objective of the TIMS CoE is to maintain, support, and develop the Novo Nordisk Test and Validation Tool, which has over 10,000 active users. The tool is used for validation and testing of GxP-critical and non-critical IT systems and equipment in Global IT, Product Supply, and NNI. This role is based in Bagsværd.
-
Quality Systems Specialist
1 month ago
Bagsværd, Denmark Novo Nordisk AS Full timeAre you a detail-oriented professional with a strong quality mindset and experience in digital validation? Do you thrive in a collaborative environment and have excellent communication skills? We are seeking a Quality Systems Specialist to join our team at Novo Nordisk A/S.The RoleThe Quality Systems Specialist will be responsible for specifying and...
-
Quality Systems Specialist
4 weeks ago
Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAs a Quality Systems Specialist in our digital validation system team, the TIMS Center of Excellence (CoE), you will be responsible for specifying and designing the best possible solution for digital validation and ensuring business and quality requirements.The digital validation system, called TIMS (Technical Information Management System), is based on ALM...
-
Quality Assurance Specialist
1 month ago
Bagsværd, Denmark Novo Nordisk Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk. As a Quality Assurance Specialist, you will be responsible for leading strategic quality projects and initiatives across our business area, driving reporting, and conducting quality management reviews. You will also liaise with and advise senior...
-
Quality Assurance Specialist
4 weeks ago
Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full timeAbout the Role:We are seeking a Quality Assurance Specialist to join our Corporate Facilities team at Novo Nordisk.Key Responsibilities:Lead strategic quality projects and initiatives across CVP areaDrive reporting and conduct quality management reviewsLiaise with and advise senior stakeholders on quality mattersReview, optimize, and strengthen quality...
-
Security System Specialist
2 months ago
Bagsværd, Denmark Novo Nordisk AS Full timeDo you have experience in managing IT systems in regulated environments? Are you seeking a role that involves ensuring compliance, providing IT specialist support, and contributing to digital developments? We are looking for a skilled Security System Specialist to join our team and take charge of the daily operations and development of our Physical Security...
-
Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full timeAbout the RoleCertainly, we are seeking a highly motivated and skilled Quality Assurance Specialist for Validation to join our CMC API QA department. As a member of this dynamic team, you will be responsible for ensuring the highest quality standards in the capacity expansion project. Your expertise will be instrumental in setting quality directions,...
-
IT System Specialist
1 month ago
Bagsværd, Denmark Novo Nordisk Full timeJob Title: IT System SpecialistNovo Nordisk is seeking a highly skilled IT System Specialist to join our Product Management team within the Manufacturing Execution System (MES) Agile Programme. As a key member of our team, you will be responsible for overseeing the installation, configuration, and qualification of our PAS-X MES system for new production...
-
Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full timeAbout the JobWe are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk. As a Quality Assurance Specialist, you will play a vital role in ensuring the quality of raw materials and packaging materials for our marketed products.Key ResponsibilitiesEvaluate, select, and approve new suppliers for raw materials, process aids,...
-
Bagsværd, Denmark Novo Nordisk Full timeAbout the RoleCMC API QA is seeking a highly skilled QA Validation Specialist to join our team. As a key member of our optimization project, you will be responsible for ensuring the quality and compliance of our CMC API facilities and equipment.Key ResponsibilitiesSetting the quality direction for the capacity expansion projectDelivering best-in-class...
-
Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full timeAbout the RoleWe are seeking a Quality Assurance Validation Specialist to join our team at Novo Nordisk, a dynamic company in the pharmaceutical industry. This role is part of our CMC API QA department, which ensures quality and compliance of facilities and equipment.As a Quality Assurance Validation Specialist, you will be responsible for setting quality...
-
Security System Specialist
4 weeks ago
Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAs a Security System Specialist at Novo Nordisk, you will play a key role as the subject matter expert for our Physical Access Control System. Your responsibilities will include supervising the installation, configuration, maintenance, and development of various GxP and non-GxP IT systems, providing subject matter expert guidance, insight, and advisory on...
-
Raw Materials Quality Assurance Specialist
2 weeks ago
Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full timeAbout the RoleWe are seeking a highly skilled Raw Materials Quality Assurance Specialist to join our team at Novo Nordisk. As a key member of our Sourcing QA department, you will be responsible for ensuring the quality of raw materials and packaging materials used in all of our marketed products.Key ResponsibilitiesEvaluating and selecting new suppliers for...
-
Security System Specialist
1 month ago
Bagsværd, Denmark Novo Nordisk AS Full timeAre you an IT professional looking for a challenging role in a regulated environment? We are seeking a skilled Security System Specialist to join our team at Novo Nordisk A/S. As a key member of our Corporate Facilities department, you will be responsible for the daily operations and development of our Physical Security IT systems.In this role, you will work...
-
IT Systems Architect
2 weeks ago
Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeWe are seeking a skilled IT Systems Architect to join our team at Novo Nordisk A/S. As a Security Operations Specialist, you will play a key role in ensuring the stability and security of our Physical Access Control System.Your responsibilities will include supervising the installation, configuration, maintenance, and development of various GxP and non-GxP...
-
Coordinating Specialist for Quality Management
4 weeks ago
Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full timeAbout the Role:We are seeking a highly skilled Coordinating Specialist for Quality Management to join our department at Novo Nordisk. In this role, you will be responsible for coordinating external audits at Contract Acceptors within the CMCQA and collaborating with other audit functions within NN where we share Contract Acceptors.Key...
-
Senior Quality Assurance Specialist
2 weeks ago
Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeWe are seeking an experienced Senior Quality Coordinator to join our Inbound Supply Management team at Novo Nordisk A/S. This role offers a unique opportunity to drive quality excellence and improve processes in a fast-paced global environment.Job DescriptionAs a Senior Quality Coordinator, you will report directly to the Senior Manager of Quality Support...
-
Senior Quality Assurance Specialist
1 month ago
Bagsværd, Denmark Novo Nordisk AS Full timeJob Title: Advanced QA ProfessionalWe are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team.About the RoleThe successful candidate will support CMC API Development within the raw material and CMO shipping area, ensuring compliance with regulatory requirements, quality standards, and company policies.Key...
-
Bagsværd, Denmark Novo Nordisk Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our Sourcing QA team at Novo Nordisk. As a key member of our team, you will be responsible for ensuring the quality of raw materials and packaging materials used in our marketed products.Key ResponsibilitiesEvaluate and select new suppliers for raw materials, process aids, and...
-
Digital Validation Specialist
2 weeks ago
Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeNovo Nordisk A/S is seeking a highly skilled Digital Validation Specialist to join our TIMS Center of Excellence (CoE) team in Bagsværd.The estimated salary for this position is approximately $90,000 - $110,000 per year, depending on experience and qualifications.About the RoleAs a Digital Validation Specialist, you will be responsible for specifying and...
-
IT System Specialist
4 weeks ago
Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full timeThe MES System Engineer RoleWe are seeking a skilled IT professional to join our team as a MES System Engineer. In this role, you will be responsible for the installation, configuration, and qualification of our PAS-X MES system across new production facilities globally.Key responsibilities will include:Overseeing the installation, configuration, and...