QA Project Specialist LCMO (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Quality

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Are you passionate about ensuring quality? Do you thrive on the opportunity to play a crucial role in Novo Nordisk’s global network of Local Contract Manufacturer Organizations (LCMOs)? Are you eager to contribute to projects that supply insulin to regions with limited access to this life-saving medication, such as South Africa, India, and other developing markets?

If so, we invite you to step into a leading role where your work will make a positive and direct impact every day. Apply now to become our new QA Project Specialist and join us in our mission to make insulin more accessible globally!

The position
In this position you will be the QA representative in project transfers from Novo Nordisk to CMOs. You will participate in various projects within Drug Products and Finished Products, working with both internal and external business partners and with a high level of complexity and independent decision making in your daily tasks.

Main responsibilities include:

• Quality responsibility for the technical transfer to the CMOs in market and capacity expansion projects and be responsible for setting the quality and compliance direction
• Taking lead in ensuring the CMO Quality Management System (QMS) is compliant to fulfil relevant GMP requirements
• You will promote good collaboration with the CMO as well as build the Quality mind-set and Compliance culture at the CMO, including activities such as to train the local CMO QA organization to maintain and improve compliant operation and to act as both coach and mentor at the CMO’s
• Negotiation and implementation of quality agreements, approving process validation strategy and related documents
• Setting up the QA processes for commercial manufacturing.
• Participating in qualification audits performed at the CMO and ensure sufficient follow up on CAPAs

Moreover, you will manage quality issues during the technical transfer such as: Process validation documentation, deviations, out of specifications, change controls, action plan and follow up, evaluate production documentation.

Expected travel is around 25 days a year as the CMOs are located outside Denmark. We are currently collaboration with CMO’s in Saudi Arabia, India, Bangladesh and South Africa and we are exploring opportunities in other countries.

You will have great professional and personal development opportunities in a well-functioning department. We can offer you a working environment with a high level of team spirit as well as highly skilled, ambitious, and engaged colleagues.

Qualifications
To succeed in this role, you:

• hold an academic degree as Pharmacist, Engineer or similar
• have a minimum of 5 years' experience from the pharmaceutical industry either from production or QA
• have a solid and up-to-date knowledge of quality and GMP requirements and have the ability to take decisions on quality representing Novo Nordisk
• are proficient in English and knowledge of other languages will be an advantage

It is an advantage if you have extensive knowledge within aseptic Drug Products.

On a personal level, you have a natural ability to take lead and work as a team player, proactively contributing to the team’s tasks and activities. You have the ability to work in an international set-up with external stakeholders with different interests and agendas, using your great communication and collaboration skills. We would enjoy welcoming a straightforward person with a good sense of humor to our department. Finally, you meet own deadlines and know how to prioritize between different tasks in an everchanging environment.

About the department
Global Contract Manufacturing (GCM) QA is responsible for quality assurance and quality support to outsourced production activities worldwide. In LMCO QA one of the primary roles is to deliver QA support and set direction for CMO’s in countries where local presence is required to maintain market access.

GCM QA is a dynamic department consisting of 70 competent people divided into 8 teams with focus on either operations or projects. You will be a strong player in the project team. The department is characterized by a high level of professionalism, flexibility, and cooperation. The primary role of our department is to deliver QA support and set direction for our global CMOs.

At the moment, the workplace is in Søborg, but at the end of 2024 we will be relocated to Høje Taastrup.

We focus on good social relations and prioritize to make room for fun at work.

Working at Novo Nordisk
At Novo Nordisk, 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 – we’re all working to move the needle on patient care.

Contact
For further information, please contact Senior Quality Manager Asger Laurberg Vig at +45 30752770 or at [email protected]

Deadline
3 October 2024

You do not need to attach a cover letter to your application, but please include a few sentences about your motivation in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

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.