Manager, Qualified Person and Quality Assurance

3d3 days ago

BeiGene

IL · Full-time · ILS 400,000 – ILS 600,000

About this role

BeiGene is seeking a Manager of Qualified Person and Quality Assurance to join our Israel operations. Reporting to the QA Director Israel, you will ensure compliance with GMP requirements set by the Israel Ministry of Health for commercial medicinal products.

Your daily work involves releasing or rejecting batches of registered and non-registered medicinal products for marketing in Israel. You will handle deviations from the Quality Management System, set corrective and preventive actions, and oversee change controls and supplier compliance.

You will collaborate with domestic and international stakeholders and facilitate inspections by regulatory authorities. This role also involves managing local GMP/GDP suppliers and supporting audit teams to assess compliance with legislative requirements.

This position offers the opportunity to stay current with evolving regulations and mentor BeOne staff. You will contribute directly to the fight against cancer while building expertise in Israeli pharmaceutical quality systems and global standards.

Requirements

A minimum of 5 years’ experience in the pharmaceutical industry as a Qualified Person with a Quality Assurance background.
Strong knowledge of Israeli pharmaceutical regulations and standards regarding GDP/GMP for import and disposition of pharmaceutical products.
Familiarity with EU relevant regulations and guidelines.
Experience interacting with the Israel Ministry of Health.
Understanding of the pharmaceutical industry and legal framework.
Proficient in Hebrew and English.
Proficiency in MSOffice (Outlook, Word, Excel, PowerPoint) and various computer programs.

Responsibilities

Release or reject batches of registered and non-registered medicinal products for marketing in Israel, including accompanying actions to comply with Ministry of Health procedures.
Ensure full compliance with Good Distribution Practices and Good Manufacturing Practice for the import and disposition decisions of pharmaceutical products.
Prepare and update controlled documents such as SOPs and forms related to the local Quality Management System.
Handle quality complaints, product returns, defects, and support the recall and mock recall process.
Manage deviations from BMI’s Quality Management System and set appropriate corrective and preventive actions.
Support the change control process and oversee the implementation of Risk Management Plans.
Participate in and facilitate inspections by regulatory authorities and work with domestic and international stakeholders.
Review Product Quality Reviews and full batch records.

Benefits

Part of a mission-driven company dedicated to fighting cancer.
Exposure to international regulatory environments and global quality compliance.
Opportunity to mentor and coach BeOne staff as part of a leadership role.
Collaboration with diverse stakeholders across domestic and international teams.