Freelancer Senior Quality Manager, Quality Assurance

TFS HealthScience; Italia; In loco; EUR 60.000 - 100.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Freelance Senior Quality Manager in Quality Assurance to join its dynamic team. In this role, you will oversee GCP activities related to clinical trials, ensuring compliance with regulatory requirements and industry standards. You will facilitate document management, support risk assessments, and prepare for audits, all while collaborating with passionate professionals dedicated to making a difference in patients' lives. This role offers competitive compensation and growth opportunities in a collaborative environment where your expertise will contribute to impactful projects.

Servizi

Competitive compensation

Growth opportunities

Collaborative environment

Competenze

• Minimum five years’ experience in clinical trials, QA, and GxP compliance.
• Strong communication and analytical skills, able to work independently.

Mansioni

• Oversee GCP activities related to clinical trials and compliance.
• Prepare sites for inspections and manage external audits.
• Assist with Computer Systems Validation (CSV) activities.

Conoscenze

GCP/GxP regulations

Clinical trial processes

Analytical skills

Communication skills

MS Office proficiency

Formazione

Degree in a scientific field

Descrizione del lavoro

Freelancer Senior Quality Manager, Quality Assurance

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. Our expertise includes full service capabilities, resourcing, and Functional Service Provider (FSP) solutions.

Join Our Team as a Freelance Senior Manager, Quality Assurance - UK, Poland, Spain, Portugal, or Italy

About this role

As part of our Quality and Compliance Department, you will work alongside passionate professionals to ensure our customers achieve their goals.

The Senior Manager, Quality Assurance is responsible for overseeing GCP activities related to clinical trials. They perform daily clinical quality operations and compliance activities to support successful clinical trial projects, ensuring processes adhere to regulatory requirements, ICH Guidelines (e.g., ICH E6 GCP), SOPs, country-specific requirements, and industry standards.

The role includes facilitating controlled document management, supporting risk assessments and root cause analyses, managing quality issues, assisting with GxP Computer System Validation (CSV), and preparing for and hosting audits and inspections.

Key Responsibilities

1. Quality Management System: Facilitate document updates, support risk assessments and CAPA plans, and promote continuous quality improvement.
2. Inspection: Prepare sites for inspections, guide staff, manage inspection processes, and host external audits.
3. Audit: Conduct and follow up on audits, support audit activities, and review audit reports.
4. Computer Systems Validation: Assist with CSV activities across the company.
5. RFIs/RFPs: Contribute to quality sections and maintain question libraries.
6. Client Interactions: Support business development, lead client visits, and meetings.
7. Support: Provide quality advice, lead investigations, and address systemic gaps and non-compliance issues.

Qualifications

• Degree in a scientific field.
• Knowledge of GCP/GxP regulations and clinical trial processes.
• Minimum five years’ experience in clinical trials, QA, and GxP compliance; CSV experience is a plus.
• Strong communication, analytical skills, and ability to work independently and within a team.
• Fluent in English, proficient in MS Office.

What We Offer

Competitive compensation, benefits, and growth opportunities in a collaborative environment dedicated to making a difference in patients’ lives.

About Us

Founded over 27 years ago in Sweden, TFS HealthScience is a global CRO delivering tailored clinical research services across therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology, with over 800 professionals in more than 40 countries.

Our core values—Trust, Quality, Passion, Flexibility, and Sustainability—guide our decisions and culture. We are committed to mutual respect, innovation, and excellence. Together we make a difference.