QA Specialist; f​/m​/d – CSV & QV

In Bern,we’renot just expanding—we’rereaching a major milestone by launching a new production site and introducing innovative ways of working. This is what being a Persistent Pioneer in our BN DNA is all about—bringing a pioneering spirit to everything we do. Whether you’rean experienced professional, transitioning from academia, or coming from a related industry,you’llhave the unique opportunity to influence how we work and grow.

In this key role, you will help ensure high quality standards and contribute to the delivery of safe and effective pharmaceutical products.

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

• Develop,reviewand approve CSV andQV strategies, plans, protocols and reports for new and existing facilities, utilities,equipment and computerized systems
• Partner with cross-functional teams such as Engineering, Manufacturing,ITandother
  
  Qualityservicesto ensure compliance andtimelyproject execution
• Participate in audits and inspections in relation to CSV andQV, ensuring readiness and robust documentation
• Drive a culture of quality, compliance and continuous improvement within CSV andQV activities, mentoring team members and stakeholders as needed
• Support changes and corrections in relationwithCSV andQV
• Act as subject matter expert (SME) for relevant regulations and guidelines, including EU GMP (Eudra Lex Volume 4, Annex 11 and 15) and FDA 21 CFR Part 11

• University degree in engineering, life sciences, computerscienceor a related field
• Minimum 5 years of experience in CSV and ideallyQV within the pharmaceutical, biotechnology or related regulated industry;
  
  Experience in QA would be 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;
  German is an advantage, combined with strong interpersonal and communication abilities

We provide an opportunity to be a part of an international company that boasts exceptional technology and a determined team. Join our team if you share our enthusiasm and have a desire to create an impact. You can expect a vibrant and adaptable work environment that supports the growth of your personal and professional skills.

Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and 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.

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