Associate Director, Global Quality North America

Protecting Our Tomorrow
At Bavarian Nordic, we aspire to save and improve lives by developing innovative vaccines that are designed to unlock the power of the immune system. We are a global leader in smallpox/mpox vaccines, and our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, typhoid fever, and cholera. We excel in R&D innovation, manufacturing, and commercialization. We aim to improve health and quality of life for children and adults around the world – protecting our tomorrow. We hope that you will share this mission with us.

Associate Director, Global Quality North America
Join our dynamic Global Quality Team to manage the present and shape the future of Bavarian Nordic Quality. Bavarian Nordic has with our recent acquisition of two established commercial vaccines and the FDA-approval of our smallpox vaccine embarked upon a truly transformative journey to become one of the largest pure play vaccine companies, improving and saving lives by excelling in R&D innovation, manufacturing, and commercialization. With the completion of our fill and finish facility at Kvistgaard (Denmark) we will be able to carry out all parts of the chain in vaccine manufacturing, and as part of this progressive journey we are now looking for an Associate Director Global Quality North America.

Core Responsibilities
Due to the expansion of Bavarian Nordic, Global Quality needs an expert to manage BN Quality operations for USA and Canada.

• Manage quality for Bavarian Nordic operations taking place in North America in collaboration with our CMO and European Quality functions, including product release, distribution quality and complaints handling
• Train relevant functions operating products to the relevant quality procedures
• Audit distribution and release partners so that their qualified status is activated or maintained
• Write Quality Agreements with partners for Distribution Quality and Release in North America
• Ensure contacts with Health Authorities in USA and Canada
• Lead and contribute to the evolution of Quality operations at Bavarian Nordic
• Communicate and ensure the visibility of the Global Quality function within Bavarian Nordic (BN)
• Elaborate and share relevant metrics
• Lead or support process improvements
• Foster a working environment where respect, human courage, collaboration beyond borders, a broad view as well as details are both in focus

Key Qualifications

• Master’s degree in Lifesciences, Pharmacy or equivalent
• Proven experience in quality management within biopharma including proficiency in Good Manufacturing Practices (at least 5 years of relevant work experience)
• Strong experience with Good Distribution Practices
• In-depth knowledge of US guidelines
• Excellent English skills, both spoken and written
• Strong level of autonomy and self-drive
• Strong skills in planning and execution
• Proven ability to develop and maintain effective relationship with external partners including Health Authorities
• You have excellent communication skills, are structured and operate with integrity and professionalism
• You are proactive and self-motivated with can-do attitude

We Offer
A chance to work in an international company with unique technology and a dedicated workforce. We welcome people who share our passion with a willingness to make a difference. We offer a dynamic and flexible work environment and an opportunity to develop both your personal and academic competencies. We offer a comprehensive benefits plan and a competitive compensation package.

Salary Range
: $160k - $220k

Location
: East Coast Preferred – Flexible on-site schedule – US Headquarters, Durham, NC

Caught your interest?
If you are interested in the position, we look forward to receiving your application via our recruitment system. Just click the Apply-Button on the right side of the page and you will be redirected to our application form.

For Us, It Is All About Improving and Saving Lives
Improving and saving lives through innovative vaccines is at the heart of what we do in Bavarian Nordic. We are a fully integrated vaccine company focused on the development, manufacturing, and commercialization of life-saving vaccines, and our vision is to become one of the largest pure-play vaccine companies in the world.

In Bavarian Nordic, we believe in the power of the team, and you will be part of a global team of +1600 dedicated people with diverse backgrounds and viewpoints who are bound together by our commitment to protect lives every day.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Department:
Durham, NC, US, Durham

Lokation: USA