Manager, QA – Ambassador for quality oversight and continuous improvement

Bavarian Nordic A/S

Fuldtidsjob
Nordsjælland

Manager, QA – Ambassador for quality oversight and continuous improvement

Would you like to set the right standards in Quality Assurance, take responsibility for quality oversight of Manufacturing and support a more lean and simple release flow across Bavarian Nordic?

Then a position as Manager for our newly established QA Review and Release team might be the position for you!

Improving health & quality of life
At Bavarian Nordic we work to develop innovative and safe vaccines to treat and prevent cancer and infectious diseases. Our aim is to improve health and quality of life for children and adults around the world. We hope that you would like to share this mission with us.

At our production site in Kvistgaard, the QA department consists of 23 employees, and has recently been expanded with an IT QA Support department. QA includes QPs, Specialists and Compliance Officers. The QA Review and Release team currently consists of 8 QA Specialists. You will manage this team and report to the Snr. Director, QA.

Raise the bar
The main task for the Review and Release team is to support and improve the daily operational tasks within review of Manufacturing, QC testing, Environmental Monitoring and Raw Material documentation.

Defining and implementing Review & Release strategy within the QA organisation
You will play an important role in defining and implementing a leaner Review and Release flow strategy together with the cross functional stakeholders.

You will also support more daily operational tasks such as:

  • Writing, reviewing and approving SOPs, Change Requests, Deviations and CAPAs
  • Keeping daily QA oversight of the release flow, release of raw material, batch review and readiness for QP approval, timely deviation handling from the different departments at the site, release of the final bulk and finished products, SOP approval, protocol and report approval
  • Ensuring that current pharmaceutical regulatory requirements, industry standards and Bavarian Nordic’s procedures are followed.
  • Taking active part in general QA improvement projects and supporting projects as such from a QA perspective

Willing and able to take responsibility
To succeed in this position the following experience and qualifications are required:

  • 3-5 years of leadership experience within QA, Pharma/Biotech
  • Deep knowledge of GMP preferably within areas of API production and finished product production
  • As our corporate language is English, you must be able to communicate fluently in English, as most documentation and procedures are written in English

As a person you thrive by responsibility within leadership and is willing and open to make decisions. You can stand firm towards stakeholders at all levels when required to ensure compliance, while at the same time being able to build good and personal relationships. You are open-minded with a good sense of humor and an outgoing and confident attitude. You thrive by planning and set an honor in implementing and performing tasks according to the plan. You are a strong ambassador of quality mind-set, but also able to apply pragmatic approaches and seeing things from a different angle.

We offer…
an exciting position in an international company with a unique technology and manufacturing process within vaccine/biologic production. As Manager in QA you will be in contact with many different departments across our three sites and you will be working in an open culture, where everybody is working in the same direction and where there is room for ideas and independent action.

Caught your interest?
If you are interested in the position, we look forward to receiving your application via our recruitment system as soon as possible. Just click the Apply-Button on the right side of the page and you will be redirected to our application form.

We are interviewing on an ongoing basis.

Further information
If you are missing some job details do not hesitate to contact Snr. Director, QA, Dorthe Kroun, on Mobile no. +45 2949 5060 or by e-mail: Dorthe.Kroun@bavarian-nordic.com.

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases. The company has a diverse and growing portfolio of vaccines, supported by proprietary development, public-private partnerships and industry collaborations. The company was founded in 1994 and has been listed on the Nasdaq Copenhagen Stock Exchange since 1998. Headquartered in Kvistgaard, Denmark and with operations in Munich, Germany and North Carolina, USA, the company employs more than 400 people. Bavarian Nordic is an Equal Opportunity Employer.

www.bavarian-nordic.com

Join Bavarian Nordic and take a step into the future of vaccines. Our goal is to develop innovative and safe therapies against cancer and infectious diseases to improve the health and quality of life for children and adults.

Søg jobbet
Ansøgningsfrist: 11/08/2019

Mere om os

Del
Kontakt os
Dorthe Kroun

Director, QA

Dorthe.Kroun@bavarian-nordic.com

+45 2949 5060


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Ansøgningsfrist d. 08.11.2019

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Hejreskovvej 10A
3490 Kvistgård
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