Svar Life Science AB · Publicerad 2 sept 2019

WANT TO BE PART OF MOVING LIFE SCIENCE FORWARD?

About the job
The Quality Manager is a critical hire for our business! Compliance and regulatory requirements in the life science market are becoming increasingly important, and you will have the chance be part of a company that is continuing to evolve and grow, pushing the boundaries of innovation, developing and launching new products which address unmet needs, for which there is sometimes little known regulation. This is a great opportunity for someone with a few years of relevant experience to expand on their knowledge while working for an innovative, dynamic company.

The role requires knowledge and experience within Quality Assurance, Regulatory Affairs, and Quality Management. The position involves managing daily activities of the Quality Team and the work is governed by regulations such as ISO13485, GLP, ISO 15189 and 21CFR820. You will lead a flexible and dedicated team with high ambitions and commitment to deliver excellent customer service and support both to our customers and different teams within Svar Life Science.

Responsibilities include:
  • Ensuring compliance with all applicable international standards and requirements and Quality Objective alignment with the business objectives and company strategy
  • Accomplishing financial objectives by forecasting requirements, preparing an annual budget, scheduling expenditures, analyzing variances, etc.
  • Managing audits and supplier/customer inspections
  • Assessing impact, and securing the implementation, of updated applicable regulations
  • Managing and developing the Quality Management System, ensuring effectiveness and continuous improvement
  • Preparing business cases for the implementation of system investments
  • System implementation including conversion, data reconciliation, user training, and documentation
  • Leading, organizing, and coordinating multiple work activities for, and the development of the Quality team
  • Participating in projects as a quality representative, ensuring on-time delivery of on-budget projects with a high degree of user satisfaction and quality
Location: Malmö

Reports to: Anna Pramhed, Vice President R&D and Quality, +46 702640588

Last day of application: 2019-09-30. Apply as soon as possible as we are working continuously with the applications.

About you

You are experienced with quality management, leading people and supporting the achievement of commercial objectives while managing risks and resources. You gain the trust of your colleagues and easily build coalitions with various stakeholders, to ensure the Quality department adequately supports the other teams within the company.

You demonstrate good communications skills, social adaptability, and humility. You have excellent written and verbal communication skills (in English), and can effectively communicate with both technical and non-technical audiences.

You see yourself as an integral player in quality management and can use your knowledge to deliver high standards and influence others, including corporate management, on quality matters. You have the ability to identify and evaluate improvements and benefits. You have a strong willingness to learn and develop within the profession, with an analytical and creative problem-solving mindset.

Experience from a regulated life science industry experience is a necessity.

About us

Svar Life Science is a Swedish company that works to enable personalized medicine by serving the global life science market with tools for drug development and companion diagnostic solutions. We deliver answers you can trust from discovery to diagnosis - our combination of high-quality products, innovative technologies, and comprehensive laboratory services are used by our customers to discover new therapeutics, diagnose patients and treat diseases. You can be sure of our answers: we’ve been working right across the clinical diagnostic value chain for more than 30 years.

Svar Life Science AB I Lundavägen 151 I 212 24 Malmö I +46 40 53 76 00 I www.svarlifescience.com
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