QA Specialist / QA Specialist

Join Our Team in Bern

We are thrilled to announce the launch of our new production site in Bern, marking a significant milestone in our journey. At Bavarian Nordic, being a Persistent Pioneer is embedded in our DNA; it represents our commitment to innovation and excellence. Whether you are a seasoned professional, transitioning from academia, or coming from a related industry, you will have a unique opportunity to shape our work and growth.

Boost Our Team

In this key role, you will play an essential part in ensuring high quality standards and contributing to the delivery of safe and effective pharmaceutical products. You will oversee and provide leadership for all Computer System Validation (CSV) activities, along with Qualification and Validation (QV) processes at the site. Your work will be crucial in ensuring compliance with regulatory requirements, internal quality policies, and industry best practices, thereby supporting 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.
• Partner with cross-functional teams such as 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 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 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

• A 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 capability 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.

Why Join Us?

At Bavarian Nordic, you will be part of an international company that is dedicated to advancing health and saving lives through cutting-edge vaccines. Our vibrant and adaptable work environment fosters personal and professional growth, and we embrace individuals who share our enthusiasm for making an impact.

Ready to Apply?

If this role aligns with your career aspirations, we invite you to apply online using the form below. Please note that only applications matching the job profile will be considered.

About Bavarian Nordic

Bavarian Nordic is a global vaccine company committed to enhancing public health through innovative vaccines. As a preferred supplier of mpox and smallpox vaccines to governments, we are dedicated to improving health preparedness. 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 and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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