Clinical Quality Assurance Manager

Elgan Pharma is a late‑stage, biopharmaceutical company dedicated to developing innovative therapies for preterm infants with unmet medical needs. Our mission is to improve clinical outcomes and quality of life for the most vulnerable newborns by advancing safe and effective treatments where no approved solutions currently exist. We are currently progressing multiple clinical programs, including pivotal Phase 3 studies in collaboration with global partners. Our strength lies in a highly collaborative multidisciplinary team that brings together deep expertise across clinical development, quality, regulatory, and operations. We cultivate a culture of professionalism, innovation, and continuous improvement, where quality is embedded in every stage of clinical research and development.

As we continue to advance our clinical programs, including pivotal studies, we are seeking a Clinical Quality Assurance (QA) Manager to support QA-related activities across our clinical trials. This role is intended for a junior-to-mid level QA professional who will contribute to the effective operation of the Clinical Quality Management System (cQMS) and supporting QA oversight activities in accordance with ICH-GCP and applicable regulatory requirements. This position reports to the Director of Clinical QA.

Key Responsibilities

• 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 templates related to clinical trial conduct.
• Support the development and execution of Study Clinical Audit Plans
• Support CRO and clinical service providers qualification and re-qualification activities
• Manage Corrective and Preventive Action Plans (CAPAs), ensuring timely resolution, effectiveness verification, and continuous improvement across clinical programs
• Review selected clinical trial documents (e.g., protocols, IBs, ICFs) from a QA and GCP compliance perspective, as assigned
• Provide QA oversight activities for CROs and clinical service providers throughout the study lifecycle
• Assist with inspection readiness activities and regulatory inspections, including preparation of documentation and follow-up actions

Role Requirements

• Bachelor’s degree or higher in Life Sciences, Pharmacy, Nursing, or a related field
• Minimum 1 year of experience in Clinical QA activities 
• Strong knowledge of ICH-GCP, FDA, EMA, and other relevant regulatory guidelines
• Experience managing CAPAs from initiation to closure, including investigation, corrective/preventive actions, and effectiveness verification 
• Proficient in computerized systems (e.g., eQMS)
• Ability to assess quality risks, identify trends, and recommend process improvements.
• Strong interpersonal, written, and verbal communication skills; ability to interact with cross-functional teams and external vendors.
• Background experience as a CRA and/or in clinical project management – significant advantage.