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 and thriving with innovation and energy, and we are looking for a passionate QA Sterility Assurance Specialist (f/m/d) to join our Quality Assurance department.

Boost Our Team

As part of a collaborative Quality Assurance organization led by the Director QA Bern, Qualified Person (FVP), you will be part of a team of dedicated professionals committed to delivering excellence and safeguarding patient health every day.

In the role of 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 focus will be 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 will be based at our manufacturing site in Bern (eligibility to work in Switzerland is required). This 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 engage directly with 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

• Developing and maintaining sterility assurance and contamination control strategies for aseptic processing.
• Leading risk assessments for aseptic processes, single-use systems, and critical interventions while ensuring compliance with relevant guidelines such as Annex 1.
• Managing 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 preparing training programs for the future.
• Mentoring operations and QA staff to reinforce contamination control culture and right-first-time behaviors.
• Staying updated on regulatory developments and updating procedures as necessary.

Your Skills and Qualifications

• Bachelor’s or Master’s degree in Microbiology, Biology, Pharmacy, or a related scientific field.
• A minimum of 5 years of experience in GMP biologics or sterile manufacturing, including over 2 years in QA sterility/aseptic leadership roles.
• 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, especially under time-sensitive conditions.
• Analytical, detail-oriented, with skills in risk-based problem solving and 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 bringing innovative ideas to the table. Solution-oriented and not afraid to take initiative, you 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 allows you to drive innovation and shape the contamination control strategy for new aseptic products. You will gain substantial organizational visibility and have the opportunity to define this position further. Join us to make a meaningful impact.

Apply Now

Ready to take the next step in your QA career and help bring critical vaccines to market? 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 head-hunters or recruitment agencies refrain from contacting us regarding this position.

Founded in 1994, Bavarian Nordic has 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. Headquartered in Denmark, we have manufacturing, research, and sales offices across Europe and North America. Our values – our Bavarian Nordic DNA – guide our actions every day: we act as persistent pioneers, embrace change, value teamwork, and believe in protecting lives every day. If these values resonate with you, we would love to have you join us at Bavarian Nordic!

Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment without discrimination based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

www.bavarian-nordic.com