Senior Quality Assurance Specialist @Bavarian Nordic GmbH

[Hiring] Senior Quality Assurance Specialist @Bavarian Nordic GmbH

Apr 01, 2025 - Bavarian Nordic GmbH is hiring a remote Senior Quality Assurance Specialist. 💸 Salary: unspecified. 📍Location: Germany.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

Become the trusted Quality Assurance Expert to our R&D QA team in the QA department!

Collaborate with stakeholders in the development department to support clinical trial programs for Bavarian Nordic compounds in our pipeline and for marketed products.
Establish appropriate activities supporting the management and oversight of quality for clinical trial programs and processes, Investigational sites and vendors.
Support inspection readiness activities.
Prepare and host inspections from regulatory authorities.
Maintain and track change control, investigations, deviations and CAPAs to closure.
Support the development and maintenance of the corporate GCP audit programs.
Perform internal and external audits as a lead auditor or as a co-auditor.
Support with oversight over subcontracted contracted audit programs.
Support development, maintenance and continuous improvement of the Quality Management System (QMS).
Participate in development projects and provide support in the context of clinical risk management.

Qualifications

University degree (B.Sc or above) in natural sciences or a comparable qualification.
Demonstrated knowledge of ICH GCP, global regulations and guidelines applicable for the conduct of clinical trials – demonstrated knowledge of pharmacovigilance strongly preferred.
Minimum 7 years of experience in QA or in quality-oriented work supporting clinical trials.
Experience of developing audit and/or quality oversight strategies in GxP areas.
Experience of 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.

Benefits

A chance to work in an international company with unique technology and a dedicated workforce.
Being part of a dedicated and agile global regulatory affairs team.
A dynamic and flexible work environment.
Opportunity to develop both your personal and academic competencies.

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📍	Be aware of the location restriction for this remote position: Germany
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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Senior Quality Assurance Specialist @Bavarian Nordic GmbH

Salary 💸 unspecified	Remote Location Germany
Job Type full-time	Posted Apr 01, 2025

️

📍	Be aware of the location restriction for this remote position: Germany
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.