Freelance Associate Director, Quality Assurance (GCP Auditor) (0.8-1.0 FTE)

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.

Join Our Team as a Freelance Associate Director, Quality Assurance (GCP Auditor) - hybrid in Warsaw, Poland / Lund, Sweden or home based in UK, Italy or Portugal.

About this role

As part of our Quality and Compliance team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Freelance  Associate Director, Quality Assurance (GCP Auditor) works very closely with the Senior Director of Quality Management and deputises for them in all areas. They will have line management responsibilities.

The Freelance Associate Director, Quality Assurance (GCP Auditor) is capable of independently conducting work related to the development, improvement and daily management of the TFS QMS as well as managing the Quality Management System and the associated documentation. They manage the Annual Audit Plan and tracking of all audits. They will also manage the recording of issues (including complaints and serious breach), managing CAPA and Computerised Systems Validation.

This person has a broad experience in clinical research and quality management and is able to provide support and advice throughout this area.

Key Responsibilities

AUDIT :

• Ensure the Annual Audit Plan is prepared, followed and maintain along with the Audit Progress Report.
• Responsible for tracking all audit types and ensuring all are completed
• Prepare, conduct and follow up on all types of internal and external GxP audits
• Support and guide operational staff in preparing for customer audits
• Responsible for hosting / facilitating customer audits of the company and / or projects
• Review and approve audit reports for other quality management personnel and provide advice and direction as required
• Act as Quality Lead Auditor when applicable

INSPECTION :

QUALITY MANAGEMENT SYSTEM :

SUPPORT :

VENDOR MANAGEMENT :

METRICS :

CLIENT INTERACTIONS :

BUSINESS DEVELOPMENT :

MISCELLANEOUS :

Qualifications

For candidates based in Italy - y ou will need to be compliant with the Italian MoH Decree dated on 15th November 2011(G.U. n°11 dated on 14th January 2012). W e also welcome applications from candidates belonging to protected categories under art. 1 L. 68 / 99.

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 29 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.