QA Specialist / QA Specialistess

Join Our Team in Bern!

We are proud to announce a significant milestone in our journey—launching a new production site and implementing innovative work practices. This is the essence of being a Persistent Pioneer in our BN DNA—infusing a pioneering spirit into everything we do. Whether you are an experienced professional, transitioning from academia, or coming from a related industry, this is your chance to influence how we work and grow.

Boost Our Team

In this essential role, you will uphold high-quality standards and contribute to the delivery of safe and effective pharmaceutical products. You will 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 to support the development and manufacture of safe, effective, and 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.
• Collaborate with cross-functional teams including Engineering, Manufacturing, IT, and Quality services to ensure compliance and timely project execution.
• Participate in audits and inspections related to CSV and QV, ensuring readiness and comprehensive documentation.
• Foster a culture of quality, compliance, and continuous improvement within CSV and QV activities, mentoring team members and stakeholders as necessary.
• Support changes and corrections in relation 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, ideally including QV, within the pharmaceutical, biotechnology, or related regulated industry; QA experience is a plus.
• Proven 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 beneficial, combined with strong interpersonal and communication abilities.

Why Join Us?

We offer an opportunity to be part of an international company that prides itself on exceptional technology and a dedicated team. If you share our enthusiasm and possess a desire to make an impact, consider joining us. You can expect a vibrant and adaptable work environment that supports the development of your personal and professional skills.

Ready to Make an Impact?

If this sounds like the next step in your career, we encourage you to apply online using the form below. 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. We are a preferred supplier of mpox and smallpox vaccines to governments, enhancing public health preparedness, and we maintain a leading portfolio of travel vaccines. Our headquarters is in Denmark, with 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.