Head of Quality Assurance

Company Description

Mapi Pharma is a late clinical stage pharmaceutical company based in Jerusalem. We specialize in the development of high barrier-to-entry and high added-value life cycle management products, as well as complex generic drugs. Our lead product, GA Depot, is a long-acting depot formulation of glatiramer acetate for treating multiple sclerosis (MS). We also have several generic commercialized products in our portfolio. Our headquarters and R&D facilities are in the Weizmann Science Park in Nes Ziona, API production facility in Neot Hovav, and aseptic depot injectable pharmaceutical manufacturing facilities located in Jerusalem.

Role Description

This is a full-time, on-site role for a Head of Quality Assurance of Mapi Pharma. The focus is on Mapi’s aseptic product pipeline of clinical development products and the supply to regulated markets. The Head of Quality Assurance will be responsible for overseeing and implementing quality control measures, conducting quality audits, utilizing analytical skills for quality management, and ensuring compliance with regulations and standards of the Israeli MoH, EMA and the FDA. The role also involves developing and maintaining quality assurance systems and processes, as well as providing leadership and guidance to the quality assurance team.

Qualifications

• Quality Control, Quality Auditing, and Quality Management skills
• At least 3 years experience in quality management of pharmaceutical aseptic production
• Analytical Skills for quality assurance processes
• Experience in implementing and maintaining quality assurance systems
• Strong knowledge of regulations and standards in the pharmaceutical industry, US FDA experience is a must
• Master's degree in a relevant field (e.g., pharmaceutical sciences, chemistry)
• Previous experience in a managerial role in quality assurance is required