Manager, Qualified Person and Quality Assurance - Israel
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.
The incumbent will report to the QA Director Israel and will be responsible for activities related to GMP operations in Israel to make sure that BeOne Medicines Israel (BMI) complies with GMP requirements as set by Israel Ministry of Health (MOH) and ensuring procedures and systems are in place to support BeOne Medicines Israel commercial products.
Essential Functions of the Job:
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).
Review of Quality Assurance Agreements (QAAs).
Handle quality complaints, product returns / defects
Support recall and mock recall process.
Handle deviations from - BMIās Quality Management System (QMS) related to imported medicinal products, product license terms, competent legislative requirements related to GMP/GDP for importers of medicinal products.
Set appropriate corrective and preventive actions (CAPA) for deviations from local QMS and MOH quality procedures for importers of medicinal products.
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.
Work with various stakeholders both domestically and internationally.
Stay current with changes in regulations and ensure the company adapts accordingly.
Oversee the implementation of Risk Management Plans
Support and review the correct implementation and maintenance of the local quality management system and ensure compliance with relevant MOH guidelines and internal policies/global standards/SOPs
Responsible for controlled Affiliate quality documentation, including uploads to the quality management system.
Provide support for artwork related matters
Support Global Quality Compliance as observer/ SME of audits - if needed to ensure compliance with quality and regulatory requirements.
Review PQRs and full batch records.
Supervisory Responsibilities:
QP
This position includes strong leadership experience, managing, coaching and mentoring of BeOne staff.
Computer Skills: MSOffice skills (Outlook, Word, Excel, PowerPoint)
Other Qualifications:
Understanding of the pharmaceutical industry and legal framework.
A minimum of 5 yearsā experience in the pharmaceutical industry as a QP and a Quality Assurance background
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.
Proļ¬cient in Hebrew and English.
Proļ¬ciency in various computer programs
Travel: May require up to 10% travel
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.
Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity
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.
The incumbent will report to the QA Director Israel and will be responsible for activities related to GMP operations in Israel to make sure that BeOne Medicines Israel (BMI) complies with GMP requirements as set by Israel Ministry of Health (MOH) and ensuring procedures and systems are in place to support BeOne Medicines Israel commercial products.
Essential Functions of the Job:
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).
Review of Quality Assurance Agreements (QAAs).
Handle quality complaints, product returns / defects
Support recall and mock recall process.
Handle deviations from - BMIās Quality Management System (QMS) related to imported medicinal products, product license terms, competent legislative requirements related to GMP/GDP for importers of medicinal products.
Set appropriate corrective and preventive actions (CAPA) for deviations from local QMS and MOH quality procedures for importers of medicinal products.
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.
Work with various stakeholders both domestically and internationally.
Stay current with changes in regulations and ensure the company adapts accordingly.
Oversee the implementation of Risk Management Plans
Support and review the correct implementation and maintenance of the local quality management system and ensure compliance with relevant MOH guidelines and internal policies/global standards/SOPs
Responsible for controlled Affiliate quality documentation, including uploads to the quality management system.
Provide support for artwork related matters
Support Global Quality Compliance as observer/ SME of audits - if needed to ensure compliance with quality and regulatory requirements.
Review PQRs and full batch records.
Supervisory Responsibilities:
QP
This position includes strong leadership experience, managing, coaching and mentoring of BeOne staff.
Computer Skills: MSOffice skills (Outlook, Word, Excel, PowerPoint)
Other Qualifications:
Understanding of the pharmaceutical industry and legal framework.
A minimum of 5 yearsā experience in the pharmaceutical industry as a QP and a Quality Assurance background
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.
Proļ¬cient in Hebrew and English.
Proļ¬ciency in various computer programs
Travel: May require up to 10% travel
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.
Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity
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.