QA Specialist (f/m/d) - CSV & QV

Über den Job

In Bern, we're not just expanding-we're reaching 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're an experienced professional, transitioning from academia, or coming from a related industry, you'll have the unique opportunity to influence how we work and grow.

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.

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.

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 in relation 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 with CSV and QV

• Act as 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

• Minimum 5 years of experience in CSV and ideally QV 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.

Are you ready to join us in our mission?

If this sounds like the next step in your career, we would love to hear from you. Simply click the "APPLY" button on the right side of the page and you will be redirected to our application form. We are conducting interviews on an ongoing basis and encourage you to apply as soon as possible.

A cover letter is not required; however, you are welcome to include one to share additional information about your experience and motivation.

Applications submitted via email will not be considered.

We kindly request that headhunters or recuitment agencies refrain from contacting us regarding this position.

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.

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