Senior Director, Quality and Compliance

Location: Casalnuovo di Napoli

2 giorni faTFS Health Science 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 work 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.

Ensure company-wide compliance through proactive monitoring, communication, and implementation of regulatory requirements.

Lead integration of regulatory changes into the Quality Management System (QMS); oversee major quality events.

Advise stakeholders on compliance strategies and risk mitigation.

Define acceptable compliance thresholds in collaboration with executive leadership, monitor performance and address deviations.

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

Oversee quality and compliance metrics reporting.

Ensure global procedures (e.g., SOPs) are current and compliant with ICH, GCP, and EU/US directives.

Optimize Q&C processes for efficiency and effectiveness.

Serve as Business System and Process Owner as assigned; maintain the Quality Manual and contribute to client/sponsor Quality Agreements.

Provide full line management for Q&C staff, including recruitment, performance evaluation, training, succession planning, and administrative oversight.

Mentor and coach team members; manage time reporting and expense tracking.

Ensure Q&C deliverables meet TFS quality standards, support whistleblowing procedures in coordination with Legal.

Contribute to cost modelling, pre-sales activities, RFPs/RFIs, and post-award documentation (e.g., MSAs) for quality/compliance services

Collaborate with senior leadership and cross-functional teams to foster a positive and productive work environment.

Audit Management Develop and execute the Annual Audit Plan.

Lead internal and external audit activities, including preparation, hosting, and follow-up.

Review audit reports and provide strategic guidance to internal auditors and participating TFS staff.

Maintain robust documentation to support compliance and business continuity.

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

Coordinate preparation of investigational sites for inspection readiness.

Support client-related regulatory inspections.

Maintain comprehensive records to ensure inspection readiness and continuity.

Quality Management System (QMS)
Oversee the electronic QMS (eQMS), including controlled documents, quality issues, and CAPAs.Ensure proper handling of complaints, potential serious breaches, fraud, and scientific misconduct investigations in line with SOPs.Additional Responsibilities Ensure vendor qualification and oversight in accordance with internal procedures.

Ensure Computer System Validation (CSV) activities and oversight in accordance with internal procedures

Perform other quality and compliance-related tasks as delegated.

Qualifications University/college degree in life science or equivalent

Minimum 10 years’ experience in clinical research, (e.g. monitoring, data management, drug safety, training, etc.)Minimum 10 years’ experience of auditing in two to three GxP areas

Minimum 10 years in compliance or relevant leadership role.

Excellent knowledge of GxP regulations and guidance. Awareness of global trends, and government policies in the clinical trials area.

Strong experience in driving the quality and compliance within CROs and their regulatory and business requirements

Strong leadership skills, problem-solving and team management

Extensive ability to deal effectively with inspectors, sponsors, and internal customers at all levels

Willingness and ability to travel

Excellent English verbal and written communication skills.

Fluency in other languages will be considered as an advantage

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 UsOur journey began over 29 years ago in Sweden, in the city of Lund. As a…