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Director of Quality Management

Helsinki, Uusimaa, Finland

€ 80.000 - 100.000

(Full Remote or Prague / Helsinki-based)Tepsivo is a young company on an ambitious mission to reshape the world of Pharma and pharmacovigilance into a modern-day industry. Since our conception in 2020, we’ve become the world’s first fully digital global drug safety provider, with a genuine end-to-end PV system run by our in-house developed tools.We’re looking for a person who can lead our quality related activities and who wants to make a dent in the PV services industry that has so far been dominated by dinosaurs relying on obsolete business models with low value-added activities and manual labor-intense processes.It’s high time for a change, and that’s what we’re here to do. Are you?What is your ideal background?– Significant experience in auditing and process improvement– Exposure to both quality assurance and quality management– Solid knowledge of international requirements, guidelines and standards– Work experience from a service provider– Understanding of how computerized systems work– Professional fluency in English– Residence in EEAJust as important – this is a role for people who are very good with computers, believe in streamlining and digitizing old-school processes, and are not afraid to challenge the established practices within industry as well as regulators.What do we expect you to do?As the Director of Quality Management, you will be at the forefront of overhauling the PV services industry. You will be responsible for our quality management system, internal auditing and quality assurance of software development, including validation. In practice this can be anything from an update of the compliance tracking process to receiving an authority inspection.We expect you to be an innovative thinker comfortable with implementing new types of quality processes. We expect you to have the ability to work independently and collaboratively. We need someone who is able to provide a thorough audit and gap analysis of any process or system leaving all the parties with a positive feeling about the experience. Last but not least, we expect you to have a solid understanding of the global legislative framework for pharmacovigilance and know what it takes to remain compliant with them.As the Director of Quality Management you will report directly to the Chief Operating Officer and you will be a member of the Senior Leadership Team of Tepsivo.General areas of responsibilities:– Operating within Tepsivo Platform and Quality Management System– Initial assessment and Gap analysis of the QMS– Planning and conducting audits– Receiving audits and inspections– Continuous monitoring and management of CAPAs– Compliance Monitoring– Risk Assessment and Monitoring– Designing Quality Objectives– Maintaining procedures related to quality assurance and continuous process improvement– Management of individuals working in different quality assurance roles globally– Ensuring the product and service teams maintain and improve their quality of work– Qualification assessment of companies and individualsWe’re a modern company and believe in a decentralized approach to management. This means we are strong supporters of providing enough freedom on where you work as well as how. Your boss will not look over your shoulder every day. Instead, you will have transparent access to key company data and objectives, and we will expect you to make informed decisions on the areas of your responsibility. In return, we expect you to be fully accountable for your own work, good or bad.This can only work with people of the right talent and those who genuinely share our values and philosophy. Tepsivo solutions have removed, automated, or otherwise digitized routine PV activities and what is left is value-added work requiring a strong skill set. If you’re selected to work at Tepsivo, that means you’re already among the best of your peers, and that is something we hope to foster and reward accordingly.If you’re ready for a true challenge, then let’s talk.Submit your CV and don’t forget to add your cover letter so we understand what motivates you about this opportunity.

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