Senior Director, Quality and Compliance

Overview

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 Senior Director, Quality and Compliance- home based in any TFS European location.

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 Senior Director, Quality and Compliance is responsible for compliance control and inspection readiness across TFS, and will work according to company policies, SOPs, and regulatory requirements.

You will be accountable for strategy, performance / delivery, compliance and operational results of the Quality & Compliance department.

Key Responsibilities

• Compliance Oversight

Maintain expert-level knowledge of relevant regulations, GxP standards, and internal procedures.

Build and lead a high-performing efficient GCP-focused Quality & Compliance (Q&C) team aligned with business goals and strategy.

Develop and execute the Annual Audit Plan.

Manage and host regulatory inspections of TFS operations, and oversee response to regulatory findings

Oversee the electronic QMS (eQMS), including controlled documents, quality issues, and CAPAs.

Ensure vendor qualification and oversight in accordance with internal procedures.

Qualifications

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.

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