Product Owner and Quality Specialist
Bagsværd
Are you passionate about spearheading digital innovation in pharmaceuticals, particularly in the realm of batch release processes? Join us as the Product Owner and Quality Specialist for our cutting-edge Digitalised Batch Release solutions and play a pivotal role in shaping the future of pharmaceutical digitalization to bring products faster to patients. Apply now for an exciting opportunity to revolutionize pharmaceutical batch release processes. The position
The Digitalised Batch Release solutions is supporting the batch records, review and release process by displaying batch-related data, required for assessment before batch status assignment, and enabling Quality Assurance / Qualified Person Delegates to evaluate data, act and conclude on the final disposition of the batch. No one wins alone and your key to success is to leverage your team and colleagues across the Q-organisation and in the Agile Release Train to turn the product vision and roadmap into action. You will be part of a strong and skilled team, working closely with the release process across Product Supply and be responsible for delivering GxP compliant solutions to the end-users. Your responsibilities will include the following: Define functionalities to be developed and implemented in collaboration with DevOps team, which are aligned with strategy and overall roadmap, while continuously adapting to emerging business needs and priorities.
Evaluate and prioritise business opportunities for the process vs. must-do compliance improvements.
Provide local support and digital insight for releasing QA in the various business areas by working closely with the process.
Collaborate with the batch review and release process of harmonising, standardising and lean the batch review and release process.
Drive situational communication supported by the organisational transformation team towards key stakeholders engaged in the product, ranging from releasing QAs and subject-matter-experts to leaders across all levels.
In collaboration with the team maximise outcomes of agile events and ceremonies, e.g. PI planning, Iteration planning, demo and retrospective.
Qualifications To be successful in this role, you need the following: University degree within Science, Engineering and/or Business.
Experience working with quality processes in GMP area, preferable in the batch release process in a pharmaceutical company.
+2 years’ experience in Agile methodologies.
Be fluent in English, both written and spoken.
i nterest in developing IT digitalisation tools.
Skilled in stakeholder management.
On a personal level, you need to inspire passion and create a feeling of ownership for people you work with. You see the big picture and can turn the strategic priorities into tangible direction for the operation and development. About the department
Inspection Office is a highly specialised area where you will join a team of 18 highly skilled, ambitious, and motivated specialists with the responsibility for handling all GMP inspections and notified bodies audits in as well as responsibility for the corporate Batch records, review and release processes. We have a close collaboration with our stakeholders globally in Novo Nordisk spanning across manufacturing sites, affiliate offices and regulatory affairs, as well as with health authorities around the world. Working at
At , we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales.
Contact
For further information, please contact hiring manager Vice President Peter Søtofte Elten or Product Manager in the ART: Lasse Harloff-Helleberg
Deadline
12 June 2024.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV.
To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At 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.
The Digitalised Batch Release solutions is supporting the batch records, review and release process by displaying batch-related data, required for assessment before batch status assignment, and enabling Quality Assurance / Qualified Person Delegates to evaluate data, act and conclude on the final disposition of the batch. No one wins alone and your key to success is to leverage your team and colleagues across the Q-organisation and in the Agile Release Train to turn the product vision and roadmap into action. You will be part of a strong and skilled team, working closely with the release process across Product Supply and be responsible for delivering GxP compliant solutions to the end-users. Your responsibilities will include the following:
Inspection Office is a highly specialised area where you will join a team of 18 highly skilled, ambitious, and motivated specialists with the responsibility for handling all GMP inspections and notified bodies audits in as well as responsibility for the corporate Batch records, review and release processes. We have a close collaboration with our stakeholders globally in Novo Nordisk spanning across manufacturing sites, affiliate offices and regulatory affairs, as well as with health authorities around the world. Working at
At , we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales.
Contact
For further information, please contact hiring manager Vice President Peter Søtofte Elten or Product Manager in the ART: Lasse Harloff-Helleberg
Deadline
12 June 2024.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV.
To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At 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.
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