Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. 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. 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.
Are you ready to become an integral part of ensuring Bavarian Nordic continues to work to the highest standards? Do you also want to work closely with colleagues from various functions and guide them toward compliance with their respective projects?
Then you might be the Senior Quality Assurance Specialist for Pharmacovigilance that we are looking for.
Boost Our Team
Become the trusted QA Expert to our R&D QA team in the Global Quality department!
In the R&D QA team, we are committed to maintaining a robust quality management system to ensure data integrity and subject safety throughout product development and post-marketing, thereby meeting regulatory requirements and expectations.
Our team is embedded in a larger quality organization, dedicated to accompanying Bavarian Nordic through an exciting phase of new products, markets, and business areas.
You will be reporting directly to the head of R&D and IT QA and be part of a team of Quality Assurance Staff located at our sites in Germany, Denmark, Canada, and the US. The team supports GCP, GCLP, and Pharmacovigilance, providing opportunities for cross-functional collaborations and interesting development opportunities.
We are looking for someone who can work in either Germany, Denmark or Switzerland.
The position can be office based, hybrid or fully remote.
This is how you impact the people we are here to serve
Our vaccines make a real difference to people, and no matter the role we all contribute to protecting lives every day. This is how your work matters:
* Support the development and maintenance of the corporate audit programs for pharmacovigilance
* Perform internal and external pharmacovigilance audits as a lead auditor or as a support auditor
* Prepare and host inspections from regulatory authorities
* Prepare and host audits from business partners
* Support quality oversight activities related to pharmacovigilance
* Maintain and track change control, investigations, deviations, and CAPAs to closure
* Support the development and continuous improvement of the Quality Management System (QMS)
* Support with oversight over subcontracted audit programs
Succeeding with our vision of protecting our tomorrow is no walk in the park, and that is why we need people like you who are determined to make it happen and have the following qualifications:
* University degree (B.Sc. or above) in natural sciences or a comparable qualification
* Minimum 7 years in the pharmaceutical or biotech industry, primarily in pharmacovigilance, with minimum 5 years of experience working in quality assurance as a pharmacovigilance auditor or in quality-oriented/compliance work
* Demonstrated knowledge of GCP is beneficial
* Experience in the conduct of internal and external pharmacovigilance audits
* Experience in preparing for and hosting regulatory inspections
* Knowledge of applied risk management and the review of continuous risk management
* Demonstrated strong analytical, problem-solving, and decision-making skills
* Demonstrated experience in managing projects
* Fluency in written and spoken English
* Knowledge of German is beneficial
Who Are You?
We're seeking someone who thrives on taking initiative and ownership, as you'll be trusted from day one and given autonomy to work without micromanagement, especially in our remote setup. You should be proactive and solution-oriented, able to work independently while staying focused on goals. Strong communication skills across all levels are essential. Maintaining effective relationships with colleagues and other departments to deliver high-quality service to the organization comes naturally to you.
You will drive your area of responsibility and have the chance to work independently as well as be part of the decision-making, as well as having a personable attitude you might be just what we are looking for.
Bavarian Nordic offers an opportunity for advancement and learning and provides flexible work-from-home possibilities.
For Us, It's All About Improving and Saving Lives
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.
At Bavarian Nordic, we believe in the power of the team, and you will be part of a global team of +1,600 dedicated people with diverse backgrounds and viewpoints who are bound together by our commitment to protecting lives every day. We believe in creating an inclusive and flexible workplace with a strong focus on personal and professional development because we need each other to take things further.
We operate in a world in constant flux and always explore new opportunities. So, if you are open-minded and have the willpower to succeed, we might just be a perfect fit for you.
Does this sound like the right job for you?
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