Manager, Qualified Person, Quality Assurance

BeOne Medicines

Manager, Qualified Person overseeing GMP operations and compliance for BeOne Medicines in Israel. Releasing batches and ensuring adherence to regulatory standards for pharmaceutical products.

Posted 6/12/2026full-timeRemote • 🇮🇱 IsraelMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

Release/reject batches of registered and non-registered medicinal products for marketing in Israel including accompanying actions to comply with the Ministry of Health (MOH) procedures.
Ensure full compliance with Good Distribution Practices (GDP) and Good Manufacturing Practice (GMP) for the import and disposition decision of pharmaceutical products.
Prepare and update of controlled documents (e.g. SOPs, forms, non-governance) related to the local Quality Management System (QMS).
Handle quality complaints, product returns / defects
Support recall and mock recall process.
Support change control process for local QMS.
Manage local GMP/GSP suppliers and support BeOne Audit teams to assess the compliance of local suppliers, with competent legislative requirements.
Participate and facilitate inspections by regulatory authorities.
Stay current with changes in regulations and ensure the company adapts accordingly.

Requirements

What you’ll need

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

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Professional development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality AssuranceGood Distribution PracticesGood Manufacturing PracticeQuality Management SystemControlled documentsChange control processRegulatory complianceQuality complaints handlingProduct returns managementPharmaceutical regulations

Soft Skills

Interpersonal communicationLeadershipOrganizational skillsAttention to detailProblem-solving

Certifications

Qualified Person (QP)