Senior Director, Quality and Compliance

TFS HealthScience; Roma; Remoto; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

A global Contract Research Organization is seeking an experienced Senior Director of Quality and Compliance to ensure compliance control and operational results. You will manage quality metrics, oversee regulatory inspections, and lead a team to drive quality within the organization. Candidates should possess extensive experience in clinical research and regulatory knowledge. This role is home-based anywhere in Europe and offers competitive compensation and growth opportunities.

Servizi

Competitive compensation package

Comprehensive benefits

Opportunities for personal and professional growth

Competenze

• Minimum 10 years’ experience in clinical research including monitoring, data management.
• Extensive ability to deal effectively with inspectors and internal customers.
• Fluency in English, other languages are a plus.

Mansioni

• Ensure compliance control and inspection readiness across TFS.
• Develop and execute the Annual Audit Plan.
• Manage and host regulatory inspections of TFS operations.

Conoscenze

Leadership

Regulatory knowledge

Problem-solving

Communication

Formazione

University/college degree in life science or equivalent

Descrizione del lavoro

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 Europeanlocation.

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.
• 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 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.