Clinical Quality Assurance (QA) Specialist | Ramat Gan

Clinical Quality Assurance (QA) Specialist

📍 On-site | Ramat Gan

🏢 Biopharmaceutical Company

A leading biopharmaceutical company is seeking a Clinical Quality Assurance (QA) Specialist to support QA-related activities across clinical trials and ensure compliance with global regulatory standards.

This role supports the effective operation of the Clinical Quality Management System (cQMS) and provides QA oversight in accordance with ICH-GCP and applicable regulatory requirements.

• Support the maintenance and continuous improvement of the Clinical Quality Management System (cQMS) in compliance with ICH-GCP, FDA, EMA, and applicable local regulations

• Assist in the development, review, and maintenance of SOPs, work instructions, and clinical templates

• Support the development and execution of Study Clinical Audit Plans

• Support CRO and other clinical service provider qualification and re-qualification activities

• Manage Corrective and Preventive Action (CAPA) plans, ensuring timely resolution and effectiveness verification

• Provide QA oversight for CROs and clinical service providers throughout the study lifecycle

• Support inspection readiness activities and regulatory inspections, including documentation preparation and follow-up actions

• Bachelor’s degree or higher in Life Sciences, Pharmacy, Nursing, or a related field

• At least 1 year of hands-on experience in Clinical Quality Assurance

Alternatively (for experienced Clinical Operations professionals):

• 3–4 years of experience as a CRA or CTM within a pharma or CRO environment

• Demonstrated exposure to QA-related activities (audit support, CAPA management, inspection readiness, quality systems)

• Clear understanding of the distinction between Clinical Operations and Clinical Quality Assurance

• Strong motivation to transition into Clinical QA as a long-term career path

This is an excellent opportunity for professionals looking to grow within Clinical QA and gain exposure to global regulatory standards in a dynamic biopharmaceutical environment.

📩 Interested? Send your CV