QA Sterility Assurance Specialist / QA Sterility Assurance Specialistess

Join Our Mission at Bavarian Nordic

Are you driven by quality, detail, and the opportunity to contribute to a mission that truly matters? At Bavarian Nordic, we are dedicated to protecting lives worldwide by developing and producing vaccines that address critical health threats. Our Bern site is rapidly expanding, thriving with innovation and energy, and we are seeking a passionate QA Sterility Assurance Specialist (f/m/d) to join our Quality Assurance department.

Boost Our Team

You will join a collaborative Quality Assurance organization led by the Director QA Bern, Qualified Person (FVP), and composed of three teams, all 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. Your role will focus on 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 at our manufacturing site in Bern. 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 Role

As the QA subject matter expert for sterility assurance, you will immerse yourself in the production environment to understand field needs and drive best practices in aseptic manufacturing. Your key responsibilities will include:

• Developing and maintaining sterility assurance and contamination control strategies for aseptic processing.
• Leading risk assessments for aseptic processes, single-use systems, and critical interventions, ensuring compliance with relevant guidance such as Annex 1.
• Overseeing 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 establishing a training framework for the coming years.
• Mentoring operations and QA staff to reinforce a contamination control culture and right-first-time behaviors.
• Staying updated on regulatory developments and revising procedures as needed.

Your Skills and Qualifications

• Bachelor’s or Master’s degree in Microbiology, Biology, Pharmacy, or a related scientific field.
• Minimum of 5 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 in 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 Are

You are a proactive problem-solver with strong communication skills, capable of navigating between teams and introducing innovative ideas. Solution-oriented and unafraid to take initiative, you thrive in a collaborative environment and are prepared to shape the contamination control strategy while contributing to the success of our aseptic product launches.

What We Offer

This role allows you to drive innovation and influence the contamination control strategy for new aseptic products. You'll gain significant organizational visibility and have the opportunity to define this position. Join us to make a meaningful impact.

Ready to Take the Next Step?

If you are prepared to advance your QA career and help bring critical vaccines to market, please apply online using the form below. Only applications matching the job profile will be considered.

Join us and become part of a diverse team dedicated to making a difference together. We kindly request that headhunting or recruitment agencies refrain from contacting us regarding this position.

About Us

Founded in 1994, we have over 30 years of experience in developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines, with a commercial product portfolio that includes market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. Our headquarters are in Denmark, complemented by manufacturing, research, and sales offices across Europe and North America. Our values—our Bavarian Nordic DNA—guide our actions every day as we act as persistent pioneers, embrace change, value teamwork, and believe in protecting lives continually.

If these values resonate with you, we invite you to join us at 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