Senior Quality Assurance Specialist - GVP

Senior Quality Assurance Specialist - GVP page is loaded## Senior Quality Assurance Specialist - GVPremote type:
Hybrid (remote and on-site) locations:
Martinsried:
Berntime type:
Full time posted on:
Posted Yesterday job requisition :
JR100840
** Senior Quality Assurance Specialist (f/m/d) - GVP
**** 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 is based in either Germany, Denmark or Switzerland.

The position can be office based, hybrid or fully remote.
** Your Responsibilities
**** 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, maintenance and oversight of corporate pharmacovigilance audit programs, including subcontracted audits
* Perform internal and external pharmacovigilance audits as lead or supporting auditor
* Prepare for and host inspections by regulatory authorities as well as audits conducted by business partners
* Support quality oversight activities related to pharmacovigilance
* Maintain and track change controls, investigations, deviations and CAPAs through to closure
* Contribute to the development and continuous improvement of the Quality Management System (QMS)
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
* Experience in the conduct of internal and external pharmacovigilance audits; demonstrated knowledge of GCP is beneficial
* Experience in preparing for and hosting regulatory inspections
* Knowledge of applied risk management and the review of continuous risk management; experience in managing projects
* Strong analytical, problem-solving and decision-making skills
* Fluency in English (written and spoken) is required; knowledge of German would be beneficial

We’re seeking someone who thrives on taking initiative and ownership, as you’ll be trusted from day one. 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.
** 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…