Job Description

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.

Working closely with the Head of Quality Management, you will contribute to the development of the overall quality strategy and play a key role in ensuring that clinical trial processes are conducted in a compliant, efficient, and scientifically robust manner.

Key Responsibilities

• Advise project teams and internal functions on quality and compliance requirements, including applicable GxP standards, international guidelines, and regulatory expectations

• Plan, coordinate, and support internal and external audits and inspections, including preparation, execution, documentation, and follow-up of findings

• Conduct risk analyses across processes and studies, assess quality and compliance risks, and derive appropriate improvement measures

• Support CAPA management activities, including root cause analysis, definition of corrective and preventive actions, and effectiveness checks

• Develop and deliver targeted quality training and support the creation, maintenance, and review of SOPs, work instructions, and other quality-relevant documentation

Qualifications

• Scientific or medical degree, or comparable background, combined with several years of experience in quality management within clinical research or life sciences

• Strong understanding of regulatory and quality requirements in clinical research, including GxP principles and end-to-end research processes

• Experience with audits, inspections, risk management, and CAPA processes, with the ability to identify process dependencies and improvement opportunities

• Fluent German and English language skills, both written and spoken, with willingness to travel nationally and internationally as needed

What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.