Are you driven by quality, detail, and the opportunity to contribute to a mission that truly matters? At Bavarian Nordic, we are on a mission to protect lives worldwide by developing and producing vaccines that tackle health threats. Our Bern site is expanding rapidly, thriving with innovation and energy, and we are searching for a passionate QA Sterility Assurance Specialist (f/m/d) to join our QA department.
Boost our teamYou will join a collaborative Quality Assurance organization led by the Director QA Bern, Qualified Person (FVP) and composed of three teams, each united by a shared mission to deliver excellence and safeguard patient health every day. As a QA Sterility Assurance Specialist (f/m/d), you will work closely with Production, Operations, MSAT, and internal QA teams, providing guidance and hands-on support for aseptic processes and contamination control. You will be dedicated to compliance, proactively identifying improvements, and shaping the contamination control strategy as we launch new aseptic products.
You will report directly to the Director QA Bern, Qualified Person (FVP), and be based in our manufacturing site in Bern. However, the position offers a hybrid work model with the flexibility to work from home 1-2 days per week, depending on business and production needs.
About the roleYou will be the QA subject matter expert for sterility assurance, working directly the production environment to understand field needs and drive best practices in aseptic manufacturing. You will develop, implement, and maintain strategies to ensure sterility and contamination control in cleanroom operations and aseptic procedures. Your responsibilities will include:
- Developing and maintaining sterility assurance and contamination control strategies for aseptic processing
- Leading risk assessments for aseptic process, single use systems and critical interventions, and ensuring compliance with authorities relevant Guidance such as Annex 1
- Lead deviations, root cause analyses, CAPA, and efficiency checks for sterility-related issues (bioburden, endotoxin, EM)
- Providing training and coaching on aseptic and sterility best practices, including setting up training for the coming years
- Mentor operations and QA staff to reinforce contamination control culture and right-first-time behaviours
- Staying updated on regulatory developments and updating procedures as needed
Your skills and qualifications
- Bachelor's or Master's degree in Microbiology, Biology, Pharmacy, or a related scientific field
- At least 4 years' experience in GMP biologics or sterile manufacturing, including 2+ years in QA sterility/aseptic leadership
- Strong background in sterility assurance or quality management within GMP-regulated environments, with expertise in aseptic processing, EM, sterilization validation, and contamination control
- Demonstrated experience in investigations (root cause analysis), CAPA, risk management, and audit interactions
- Excellent communication, collaboration, and decision-making skills under time-sensitive conditions
- Analytical, detail-oriented, and skilled in risk-based problem solving with a continuous improvement mindset
- Full professional proficiency in English; basic German is an advantage
Who you areYou are a proactive problem-solver with strong communication skills, able to navigate between teams and bring new ideas to the table. You are solution-oriented, not afraid to take initiative, and thrive in a collaborative environment. You are ready to shape the contamination control strategy and contribute to the success of our aseptic product launches.
What we offer
This role lets you drive innovation and shape contamination control strategy for new aseptic products. You'll gain strong organizational visibility and have the opportunity to define this position. Join us to make a meaningful impact.
Ready to take the next step in your QA career and help bring critical vaccines to market?Please complete the application form using the "Apply" link. We are interviewing on an ongoing basis and look forward to receiving your CV as soon as possible. It is not mandatory to send a cover letter. Applications submitted via email will not be considered.
Join us and become part of a diverse team dedicated to making a difference together. We kindly request that head-hunters or recruitment agencies refrain from contacting us regarding this position.
Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values - our Bavarian Nordic DNA, as we like to call it - are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
www.bavarian-nordic.com
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