QA Specialist for Quality Control, Raw Materials & Warehouse (F/M/D)

QA Specialist (f/m/d) – partnering our Quality Control department
Would you like to be part of a dedicated and very skilled QA team supporting the Quality Control laboratory with analytical method validations, analytical equipment qualifications and stability studies? Are you motivated by a diverse job profile that keeps your days interesting as well as filled with new challenges and opportunities for problem solving? Then a position as QA Specialist will be a great fit!

The position is based in Munich/Germany or Kvistgaard/Denmark. The position would require you to be able to be on site regularly.

About the team
QA at Bavarian Nordic is a growing department and currently consist of 4 teams within QA Operations: Drug Substance, Drug Product, EQ (Equipment Qualification)/ ENV (Environment), QC, RM and Warehouse.

Your future team, QA for QC, Raw Materials and Warehouse, consist of 11 employees located in both Germany (2) and Denmark (9).

The team handles cases from the QC labs in Denmark and Germany for release results, stability as well as validation and qualification of analytical methods and equipment.

In this position you will report to the Senior QA Manager for QA Operations.

This is how you impact the people we are here to serve
Our vaccines make a real difference to people, and no matter your role we all contribute to protecting lives every day. This is how your work matters:

• Primary advisor and functional expert to our QC department
• Fostering a quality mindset within the assigned business unit
• Ensuring quality oversight & compliance within the assigned business unit
• Reviewing and approving of SOPs, change control, QA approval of deviations as well as guidance during root cause analysis
• Daily coordination and prioritization of:
  • Review and approval of protocols and reports for Analytical Method Validation and Equipment Qualification
  • Review and approval of stability protocols and reports
  • Review and approval of OOS investigations
• Driving optimization projects related to Quality Control

Are you our next pioneer?
Succeeding with our vision of becoming one of the largest pure-play vaccine companies in the world is no walk in the park, and that is why we need people like you who are determined to make it happen and have the following qualifications:

• MSc within Pharmacology, Biochemistry, Microbiology, Virology or similar
• Relevant job experience of 5 years in QA within the life science/ biotech industry
• In-depth expertise of GMP standards
• Extensive experience with quality risk management and systematic problem solving
• Extensive experience in analytical method validation and equipment qualification
• Fluent in English, German is a plus
• Great stakeholder management and engaging communication style

Who are you?
As a person, you are structured and thrive on solving new challenges daily. You enjoy being part of a team but appreciate having your designated area of responsibility.

In addition, you manage to find pragmatic solutions without compromising on product quality. Communication with collaborators comes naturally to you.

We value a candidate with an eye for details, yet at the same time being able to set things in perspective and see the big picture.

It is therefore important that you have a natural diplomatic approach to cooperation and know how to adapt your communication to different partners. In addition, it is an advantage that you are proactive and actively contribute to implementing improvements that make daily life run easier.

We offer
At Bavarian Nordic, you will be part of a global team of +1600 dedicated colleagues worldwide, all passionate about making a difference. We offer an inclusive and flexible workplace with a strong focus on personal and professional development, and welcome people who passion for saving lives. If you are open-minded and have the willpower to succeed, we might just be a perfect fit.

Our employees also have the advantage of being able to use our bus route, 70E, which runs from Humlebæk Station directly to our production facilities in Kvistgaard. The bus has four departures every morning and afternoon with scheduled stops at Hørsholmvej and Kvistgaard St.

The new service improves the commuting experience to and from Kvistgaard, where some of our employees can now benefit from a significant time savings of almost 40 minutes each way, making their daily commute more efficient and convenient.

Do we have your attention? Ready-Set-Apply!
We are interviewing on an ongoing basis and look forward to receiving your application as soon as possible. We cannot wait to get to know you better!

Department:
Fraunhoferstrasse 13 , Martinsried

Lokation: Denmark