Quality Manager
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Job Location:
Monthly Salary:
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
Key Skills
About Company
TFS HealthScience is a global, mid-sized contract research organization (CRO) partnering with biotechnology and pharmaceutical companies across the full clinical development lifecycle. Our expertise spans full-service clinical development, project-based support, strategic resourcing, ... View more
