Clinical Quality Assurance

Company Description

ELGAN Pharma is a biotechnology company focused on neonatology, dedicated to developing safe and tailored therapies to address the medical problems and developmental difficulties common in babies born very early. The company is named after Extremely Low Gestational Age Newborns (ELGANs), babies born more than three months before term, and passionate about improving their outcomes and quality of life. ELGAN Pharma aims to reduce the number of newborn deaths, which are predominantly caused by premature birth complications, at a global level.

Role Description

ELGAN Pharma is seeking a Clinical Quality Assurance professional for a full-time, onsite role located in Ramat Gan. We are looking for someone who will be responsible for establishing, implementing, and maintaining the quality systems for clinical studies. The successful candidate will also ensure compliance concerning cGMP, ICH, and other regulatory standards in clinical development and manufacturing, as well as hosting audits from regulatory agencies or from partners.

Qualifications

• Bachelor's or master's degree in life sciences, pharmacy, or a related field is required
• A minimum of 5 years' experience in a clinical quality assurance role in pharma
• Experience in working with clinical trials phases I to III
• Fluency in English and Hebrew
• A strong understanding of cGMP, ICH, and other regulatory standards
• Ability to communicate clearly and effectively in both written and verbal communication
• Ability to work independently while being a team player in a dynamic, fast-paced environment
• Strong problem-solving skills with attention to detail