Director Quality Assurance lead Israel
BeiGene
Israel Remote, Unknown
Contract
Competitive
OfficeDirector
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
This role is responsible for maintaining the local Quality Management System (QMS) for the Israel affiliate, ensuring full compliance with Israeli regulatory requirements (MOH) and BeOne global quality standards. The position includes execution of the Qualified Person (QP) function, with accountability for batch certification, product release, and overall patient safety.
The role provides end‑to‑end quality oversight for the affiliate operating as Marketing Authorization Holder (MAH) and importer, including governance of GxP activities and management of third‑party logistics providers (3PLs) to ensure compliant importation, storage, and distribution in line with GDP requirements.
Reports functionally and hierarchically to the Senior Director, Quality - New Markets.
The role is based in Israel (preferably Tel Aviv) and requires fluency in Hebrew and English.
Essential Functions of the Job:
Establish, implement, and continuously maintain the local Quality Management System for the Israel affiliate in full compliance with Israeli Ministry of Health (MOH) requirements, applicable GMP/GDP regulations, and BeOne global quality standards.
Ensure end‑to‑end quality oversight of all GxP activities, including importation, storage, distribution, and disposition of medicinal products, maintaining full compliance with GDP and GMP requirements.
Perform Qualified Person (QP) responsibilities, including certification and batch disposition decision of medicinal products to the Israeli market, ensuring compliance with Marketing Authorization and MOH requirements.
Provide effective quality oversight and governance of all third‑party service providers (e.g., 3PLs, distributors, suppliers), including qualification, audit support, performance monitoring, and maintenance of Quality/Technical Agreements.
Responsible for the establishment, oversight, and continuous improvement of the affiliate Quality training program, including assignment and maintenance of training curricula for GxP-personnel, ensuring all GxP-personnel are appropriately trained and qualified in accordance with MOH requirements, GMP/GDP standards, and BeOne global quality expectations.
Responsible as lead investigator for deviations, CAPAs, change controls, complaints, temperature excursions, returns, recalls (including mock recalls), and product destruction, ensuring timely execution and compliance with regulatory expectations.
Ensure inspection readiness and act as local quality host for MOH inspections and internal audits, including preparation, coordination, and follow‑up of inspection outcomes and commitments.
Maintain full accountability for affiliate quality documentation, including SOPs, controlled documents, and records within the QMS, ensuring accuracy, completeness, and inspection readiness.
Accountable for QA oversight of product launch activities within the affiliate, including management and approval of launch‑related change controls to ensure all changes are appropriately assessed, implemented, and compliant with MOH requirements, GMP/GDP standards, and BeOne global quality expectations.
Support regulatory submissions, variations, and lifecycle management activities by providing quality input and ensuring alignment with regulatory and internal requirements.
Review batch documentation and Product Quality Reviews (PQRs), ensuring completeness and compliance with applicable standards.
Support artwork-related quality activities and ensure implementation of risk management principles across local operations.
Ensure continuous alignment of global quality policies with local regulatory requirements, proactively monitoring regulatory changes and adapting local processes accordingly.
Collaborate cross‑functionally with internal and external stakeholders to ensure compliant execution of all quality‑relevant activities across the product lifecycle.
Supervisory Responsibilities: N/A
Computer Skills: MS Office skills (Outlook, Word, Excel, PowerPoint)
Other Qualifications:
Hands-on personality with strong cross‑functional collaboration skills, with experience working closely with Regulatory Affairs, Supply Chain, Commercial, Medical, and Global Quality functions.
Licensed Pharmacist (Israel) with experience in the biotechnological and/ or pharmaceutical industry, including a strong Quality Assurance background and demonstrated experience performing Qualified Person (QP) responsibilities.
Deep understanding of Israeli pharmaceutical regulations (MOH) and applicable GMP/GDP requirements for the importation, certification, and distribution of medicinal products, with solid knowledge of EU regulatory frameworks and guidelines.
Proven experience operating within an affiliate MAH/importer model, including close collaboration with distributors, third‑party logistics providers (3PLs), and external service partners.
Strong capability to establish, implement, and maintain an effective local Quality Management System (QMS) aligned with local regulatory requirements and global quality standards.
Demonstrated experience in interactions with health authorities, including preparation for and participation in regulatory inspections and audits.
Highly collaborative team player with strong ownership, accountability, and reliability, capable of working effectively across local, regional, and global stakeholders.
Excellent communication and interpersonal skills, with fluency in Hebrew and English, and the ability to clearly articulate complex quality and regulatory topics to diverse audiences.
Solid project management and organizational skills, with the ability to manage multiple priorities, timelines, and stakeholders in a dynamic affiliate environment.
Advanced problem‑solving, critical thinking, and decision‑making capabilities, with the ability to address complex quality topics.
High level of proficiency in quality systems and digital tools (e.g., Veeva, ComplianceWire, and standard business applications), ensuring data integrity, training compliance, and inspection readiness.
Strong influencing and presentation skills, with the ability to drive quality culture and ensure alignment with both internal stakeholders and external partners.
Ability to stay current with regulatory developments and proactively adapt local processes to ensure ongoing compliance and continuous improvement.
Travel: yes (10-20%)
NA
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.