Quality Engineers with strong project management and consultancy skills

Do you want to bring your combination of quality related and technical knowledge to life in a job where engineering and consulting go hand in hand with the vision of making people go home smarter?

At NNE Pharmaplan we are devoted to life science and helping companies like Novo Nordisk, AstraZeneca and Roche bring vital treatments to patients worldwide. If you are looking for that small adventure that goes into your blood, then keep on reading and see if you are the Senior Project Quality Manager or Senior Quality Consultant we are looking for.

You will join the Quality & Validation department. Employees in this department provide quality and validation services and management in projects, GMP production support and consulting services for major customers in the pharmaceutical and medical device industry. Comprising a project portfolio of some 3000 projects, we guarantee a job where no two days are the same.

Your job
As Senior Project Quality Manager you will have overall quality responsibility for large-scale engineering projects within the pharmaceutical and biopharmaceutical industry. You will report to the project director and define the overall quality strategy and plan for the project, and you secure the execution of activities on budget and on time. You will manage the quality project team, consisting of up to 20 professionals, making sure that we deliver on the customer’s requirements and in compliance with the standards and regulations.

As Senior Quality Consultant your tasks will come in all shapes and sizes – with planning and executing the quality services as a common factor. As such, you could be coordinating activities in mid-sized and minor projects, validating equipment for a production or work deep in the customer organisation in a limited time. You may report to either a direct customer or to a senior project manager.

Both positions will bring close cooperation with colleagues in QA functions across the organisation and different customers.

Your qualifications
Above all, your technical background should typically cover an engineering degree combined with a strong track record driving QA activities in a pharmaceutical environment. In other words, you are highly conversant with overall quality activities, strategies, regulation, change control issues, non-conformities, equipment qualification and maybe process and cleaning validation. To be taken into consideration, you need insight into the ICH and ISPE guidelines and no further introduction to the following:

  • Quality Planning
  • DQ, IQ, OQ, PQ
  • FAT/SAT
  • EU GMP (Part I + II) and FDA 21 CFR Part 210/211

Moreover, your project management toolbox is loaded, and besides English fluency, you must speak and write Danish similar to a native.

Your personal profile
If you can enjoy a visible role where you are the point of contact to customers, you have probably just moved one step closer to becoming our future colleague. In your perspective, achieving results means that you apply a motivational approach to make team members realise their objectives and that you listen before taking action. This also requires a comprehensive view and good communication skills. Lastly, you have a strong sense of urgency and are able to navigate safely among many stakeholders, changing priorities and different locations of work.

Contact
If you want to know more about the position, please contact Director, Søren Ærenlund, telephone +45 30 79 88 77 or Manager, Jan Linke, telephone +45 30 79 69 42.

Application
Please submit your application online via nnepharmaplan.com/Career/Jobs as soon as possible.