Senior QA Managers

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We are looking for three Senior QA Managers to our team in Stockholm.

As Senior QA Manager you will have an important role in Vironova’s further business and development journey and the continuous quality work of Vironova's services and products. You will be able to work with both short-term operative tasks and long-term strategic tasks in a highly dynamic environment. You will be part of an experienced quality team and report to the Quality Director of Vironova. We are located in modern premises with good commuting opportunities in central Stockholm

Depending on your previous competence and experience you will take the role as QA for GLP-studies, QA for our GMP-laboratory or QA for internal projects with focus on validation and qualification activities.

You will:

  • Actively work to ensure that the operations within our laboratories meet GMP and/or GLP requirements and assess our compliance to the regulations
  • QA approve deviations, CAPAs, changes, unexpected test results and complaints
  • Participate in validation activities and QA approve validation documents for both analytical methods and equipment and computerized systems
  • Write, review and QA approve standard operating procedures (SOPs) and other governing documents
  • Plan, take active part in and report outcome of external audits and internal self-inspections
  • Communicate with customers regarding e.g. QA agreements and questionnaires
  • Evaluate and approve suppliers
  • Take active part in the further building of our quality and improvement culture and our quality management system and processes for delivering high quality services and products
  • Contribute to the continuous monitoring of the business quality performance and being active in quality and management reviews
  • Take part in our operational excellence work to continuously improve and learn with the possibility to act as a project leader for cross-functional improvement projects

What you need to be successful:

This is senior roles and we expect you to have extensive experience from quality and improvement work within pharmaceutical industry. 

  • Preferably Bachelor of Science in chemistry, biology, medicine, pharmacy, engineering or similar
  • Deep knowledge of the regulatory requirements in the pharmaceutical industry and documented training in “GxP”
  • Practical experience of working with investigations and assessments of deviations, CAPAs, changes and risk management
  • Practical experience of analytical method validation
  • Practical experience of validation/qualification of equipment and computerized systems
  • Experience of project management, operational excellence with LeanSigma methodology, GAMP5 and/or quality management with ISO9001 is a merit

As a person you need to be analytical, structured, and accurate. You are expected to take initiatives and drive your projects with high quality from start to finish. You have a customer focused approach, strong personal integrity in quality matters and excellent communication and social skills. You have a positive and improvement-oriented mindset and enjoy working in a highly dynamic environment where the prioritizations can change one day to another. You cooperate with colleagues within the Quality department as well as other departments with a joyful approach and you are not afraid of helping out with tasks outside your normal responsibilities.

 

Interested? Do not hesitate to submit your application today. We will review applications on an ongoing basis.

Vironova AB was founded in 2005 as a result of interdisciplinary research at the Karolinska Institute in Stockholm, Sweden and is today a fast growing company with around 130 employees including subsidiaries. We offer comprehensive hardware, software, services for the analysis of nanoparticles and virus clearance studies. Vironova revolutionizes access to transmission electron microscopy–based image analysis in biopharmaceutical development. Our solution enables automated analyses for faster and better-informed decisions to secure robust bioprocessing and final product quality.

Or, know someone who would be a perfect fit? Let them know!

Stockholm

Gävlegatan 22
113 64 Stockholm Directions View page

Workplace & Culture

We value diversity, having employees from more than 15 different nationalities. We believe it creates an evolving working environment and makes it more fun at work!

We see us as pioneers within our field and are proud and passionate about what we do. We are committed and understand the importance of accuracy to deliver high quality services.

Already working at Vironova ?

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email
@vironova.com
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