Associate Director, Global Quality North America - Durham, United States - Bavarian Nordic A/S

Bavarian Nordic A/S Durham, United States

3 weeks ago

Description

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
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.

Founded in 1994, we have more than 25 years of experience in developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies and tick-borne encephalitis and an Ebola vaccine.

We are a global company headquartered in Denmark with a state-of-the-art production facility and sites in Germany, Switzerland, and USA.

Our values – our Bavarian Nordic DNA, as we like to call it – are what guide our actions every day.

We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day.

If that is also a part of your DNA, we invite you to join us in Bavarian Nordic Bavarian Nordic is an Equal Opportunity Employer.

www.bavarian-Join Bavarian Nordic a fully integrated vaccine company focused on the development, manufacturing and commercialization of life-savings vaccines.

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