Clinical Quality Assurance Specialist

18 ore fa

Siena, Toscana, Italia PHILOGEN A tempo pieno

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.

The successful candidate will be responsible for assessing compliance with SOPs, GxP standards, European and local regulations, applicable guidelines, and clinical study protocols. This role will closely collaborate with other functions within the Clinical Department to ensure the highest standards of quality and regulatory compliance across all clinical activities.

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.
  • Comprehensive understanding and application of clinical research principles, concepts, and practices.
  • 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

We invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003. Our recruitment adheres to the provisions of Legislative Decree 198/2006, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief.

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