QUALIFICATIONS:

• Bachelor degree in a related discipline
• At least 5 years of industry experience
• Good knowledge and understanding of ICH-GCP
• Excellent communication skills
• Good planning, organisation and problem-solving abilities
• Advance user of MS Office applicationsDemonstrated ability to multitask, prioritize, and complete objectives

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. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference

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 Quality Manager is responsible for the maintenance and further development, and the communication of high-quality standards in the delivery of clinical studies.
As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical company.
This is a hybrid role, with 3 days on-site.

KEY RESPONSIBILITIES:

• Support and guide operational staff in preparing for audits
• Assist with supporting and guiding operational staff in preparing for inspections including analyse risks and develop inspection readiness strategy
• Prepares and presents training as appropriate
• Participate in internal meetings as required and liaise with other departments as necessary
• Maintain required knowledge of applicable regulations and company standards and procedures