Project Manager Quality Systems

4 days ago

Gothenburg, Västra Götaland, Sweden TFS Full time 70,000 - 120,000 per year
About this role

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions.

The Project Manager Quality Systems (NMI/Medical Software) is responsible for leading the establishment, implementation and continuous improvement of a compliant quality management system for non-medical information systems and medical software within a complex stakeholder landscape. The role includes driving strategy, structure, processes and technical documentation aligned with applicable regulations and standards.

As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical or healthcare focused organization that is an industry leader in digital health solutions and medical software development.

Assignment Duration

The assignment runs until , with an optional extension to

Key Responsibilities
  • Lead the development and implementation of a compliant quality management system for NMI and medical software
  • Conduct organizational and process mapping across involved departments and stakeholders
  • Define governance structures, roles and processes for development, lifecycle management and maintenance
  • Develop frameworks, templates and structure for technical documentation
  • Coordinate and engage stakeholders at regional, national and cross functional levels
  • Ensure alignment with regulatory requirements and relevant standards
Qualifications
  • Minimum 5 years of documented experience developing QMS for medical software, NMI or medical devices in line with MDR, IVDR or HSLF FS 2022:42
  • Strong experience in processes for governance, development and lifecycle management of medical software or NMI
  • Documented experience preparing technical documentation for medical software or NMI
  • Experience leading similar initiatives within large healthcare organizations, regional entities or comparable complex environments
  • Strong analytical, communication and presentation skills with the ability to adapt messaging to different audiences
  • Fluency in Swedish, both written and verbal
What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full service, global Contract Research Organization (CRO), we build solution driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. Together we make a difference.

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