QA Specialist Commercial Release

Are you driven by quality, detail, and the opportunity to contribute to a mission that truly matters? Are you ready to make an extraordinary impact? At Bavarian Nordic, we are on a mission to protect lives worldwide by developing and producing vaccines that tackle health threats. Our Bern site is expanding rapidly, brimming with innovation and energy, and we are searching for a passionate Quality Assurance (QA) Specialist to join our team. This is your chance to be part of something bigger, work alongside devoted experts, and shape the future of global health in one of the most dynamic environments out there!

Boost our team

You will join a tightly knit Quality Assurance organization led by the site QA (FvP/QP) and composed of three collaborative teams, each united by a shared mission to deliver excellence and safeguard patient health every day:

• QA Operations team, dedicated to the review of batch records and close partnership with production teams
• Compliance QA team, overseeing change requests, managing deviations, and ensuring precise regulatory documentation, process validation, inspections, QMR, and PQR
• CQV (Commissioning, Qualification & Validation) team, responsible for validation activities, engineering oversight, and IT QA

Our Bern QA department is a collective of skilled and seasoned professionals, renowned for their unwavering standards and supportive spirit-proud custodians of quality who thrive on collaboration and a culture of helpfulness.

About the role

As a member of our QA team, you will work side by side with our Qualified Person (FvP), directly influencing the release and distribution of life-saving vaccines across Switzerland and worldwide. You will play an essential role in ensuring our products are distributed safely, legally, and in compliance with regulatory requirements.

Your key responsibilities will include:

• Supporting FvP duties to ensure compliance with Swissmedic and GDP/GMP regulations
• Serving as direct support to the Qualified Person (FvP) for Imported products and Distribution in the Swiss market
• Coordinating products entering the Swiss market, including managing withdrawals or recalls related to released products
• Coordinate product release and batch disposition for both Swiss and international markets
• Ensuring alignment with current pharmaceutical regulatory requirements and industry standards, as well as BN quality standards and procedures
• Providing guidance on quality and compliance matters to departments at Bavarian Nordic and managing relevant QMS records as QA
• Participating in or leading quality improvement projects in collaboration with other Bavarian Nordic departments and support function visibility across the organization
• Managing and reviewing quality documentation, such as certificates and change controls
• Collaborating with internal teams, including Supply Chain & Planning, QA Operations, Audit Group, and external authorities (e.g., Swissmedic, EMA, FDA)
• Contributing to audits, vendor qualification, risk management, and continuous improvement efforts

Qualifications:

• MSc in Pharmacy or an equivalent academic degree in Chemistry, Biology, or Life Sciences
• At least 3 years of experience in Quality Assurance within the pharmaceutical industry or in related roles
• Comprehensive knowledge of GMP, GDP, and international regulatory standards including Swissmedic, Swiss federal laws and regulations governing wholesales
• Demonstrated leadership in audits, regulatory inspections, and preparation for Swiss Health Authorities site inspections
• Full professional proficiency in both German and English

As a person, we expect you to have a strong quality mindset who is ready to step up and make a difference, not only by performing the daily tasks, but also by challenging the status quo and harmonizing practices across teams and geographies. You have a sharp eye for detail and combine strong analytical skills with proactive thinking. You are an effective communicator and a collaborative team player, yet also highly self-motivated, independent, and accountable.

About Bavarian Nordic

Improving and saving lives through innovative vaccines is at the heart of what we do at Bavarian Nordic. We are a fully integrated vaccine company focused on the development, manufacturing, and commercialization of life-saving vaccines, and the largest pure-play vaccine company in the world.

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