QA Specialist / QA Specialistess

Join Our Team in Bern

At Bavarian Nordic, we are excited to announce the launch of our new production site in Bern, where we aim to innovate and redefine the way we work. This endeavor exemplifies our commitment to being Persistent Pioneers, bringing a pioneering spirit to every aspect of our operations. Whether you are an experienced professional, transitioning from academia, or shifting from a related industry, we invite you to play a pivotal role in shaping our future.

Boost Our Team

In this key role, you will help ensure high-quality standards and contribute to the delivery of safe and effective pharmaceutical products. You will oversee and provide leadership for all Computer System Validation (CSV) activities as well as Qualification and Validation (QV) processes at the site. Your efforts will ensure compliance with regulatory requirements, internal quality policies, and industry best practices while supporting the development and manufacture of compliant products.

Your Tasks

• Develop, review, and approve CSV and QV strategies, plans, protocols, and reports for new and existing facilities, utilities, equipment, and computerized systems.
• Partner with cross-functional teams such as Engineering, Manufacturing, IT, and other Quality services to ensure compliance and timely project execution.
• Participate in audits and inspections related to CSV and QV, ensuring readiness and robust documentation.
• Drive a culture of quality, compliance, and continuous improvement within CSV and QV activities, mentoring team members and stakeholders as needed.
• Support changes and corrections related to CSV and QV.
• Act as a subject matter expert (SME) for relevant regulations and guidelines, including EU GMP (EudraLex Volume 4, Annex 11 and 15) and FDA 21 CFR Part 11.

About You

• University degree in engineering, life sciences, computer science, or a related field.
• A minimum of 5 years of experience in CSV and ideally QV within the pharmaceutical, biotechnology, or related regulated industry; experience in QA is a plus.
• Demonstrated ability to drive and coordinate complex validation projects in a cross-functional environment with multiple stakeholders.
• In-depth knowledge of cGMP, GAMP, FDA, EMA, and other relevant regulations and guidelines.
• Strong technical writing, problem-solving, and project management skills.
• Excellent written and spoken English skills; proficiency in German is an advantage, complemented by strong interpersonal and communication abilities.

We provide an opportunity to be part of an international company renowned for its exceptional technology and dedicated team. Join us if you share our enthusiasm and seek to make a meaningful impact. You can expect a vibrant and adaptable work environment that fosters your personal and professional growth.

Ready to Join Us?

If this position aligns with your career aspirations, we would love to hear from you. Apply online using the form below. Please note that only applications matching the job profile will be considered.

Bavarian Nordic is a global vaccine company dedicated to improving health and saving lives through innovative vaccines. As a preferred supplier of mpox and smallpox vaccines to governments, we enhance public health preparedness and maintain a leading portfolio of travel vaccines. Headquartered in Denmark, we have manufacturing, research, and sales offices across Europe and North America.

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.

For more information, visit www.bavarian-nordic.com.