**Location: Siena - Italy** ** - **Department: Clinical** - **About Philogen**
Philogen S.p.A. is a biotechnology company dedicated to developing targeted products for the imaging and treatment of life-threatening diseases, with a strategic focus on oncology. Our mission is to translate cutting-edge scientific innovation into effective therapies that improve patients’ lives.
- **Position Overview**
In preparation for the expansion of its clinical activities, **Philogen S.p.A.** is strengthening its **Clinical Quality Assurance (CQA)** function. To this end, we are seeking a **Clinical Quality Assurance Specialist (GCP)** to join our team.
- **Key Responsibilities**- Maintain GCP/ICH-compliant systems and processes to ensure the quality of work and clinical trials conducted in Europe and the United States.
- Write and/or review clinical Standard Operating Procedures (SOPs) and support continuous process improvement initiatives.
- Manage and deliver staff training on company procedures, GCP regulations, and documentation systems.
- Qualify and audit Contract Research Organizations (CROs) and other vendors involved in clinical activities.
- Oversee documentation control within the Trial Master File (TMF) and perform quality reviews of clinical trial essential documents (e.g., Protocols, Investigator’s Brochure, CRFs).
- Conduct internal system audits and TMF checks throughout the lifecycle of clinical trials/programs to ensure compliance with internal procedures and regulatory requirements.
- Identify, document,



and report significant clinical quality deficiencies and risks to management, and actively contribute to issue resolution.
- Perform clinical site GCP audits to verify that studies are conducted in accordance with sponsor protocols, GCP principles, and applicable regulatory standards.
- Take a lead role in preparing the company and clinical sites for client audits and regulatory GCP inspections, and act as a Subject Matter Expert during inspections. **Requirements**- Master’s or Ph.D. degree in Biology, Biotechnology, Life Sciences, or a related scientific discipline.
- 3-5 years of experience in **Clinical Quality Assurance** or **Clinical Quality Oversight** within the pharmaceutical or biotechnology industry.
- Excellent command of English, both written and spoken.
- Strong attention to detail and excellent organizational skills.
- Proven ability to work independently and to prioritize tasks effectively, both individually and within a team.
- Excellent interpersonal and communication skills, flexibility in managing multiple priorities, and motivation to take on new challenges. **What We Offer**- A professional and collaborative environment focused on scientific excellence and quality.
- A contract and compensation package commensurate with experience and seniority.
- Opportunities to grow within an innovative biotechnology company at the forefront of clinical research and development. **Location**: - Siena, Italy

📌 Clinical Quality Assurance Specialist (Gcp) (Siena)
🏢 Philogen
📍 Siena