QA Professional Leader CMO

Kamada is seeking a professional lead to manage all QA activities of a CMO (contract manufacturing organization) and to prepare release packages for CMO products for release by the QA manager.

The role includes:

1. Review of batch records and lots prior to transfer to the QA manager for batch release to market.
2. Review and approval of deviations.
3. Responsibility for the day-to-day operation of Kamada’s quality systems related to CMO: quality notifications, documents and specifications, deviations, change controls, complaint investigations, stability, and annual reports.
4. Writing annual reports for CMO products.
5. Preparation for and participation in external and regulatory GMP audits.
6. Conducting GMP quality audits.

Full-time position, based in Rehovot.

Role requirements (prior experience, education, technical skills, soft skills):

• BSc – Sciences, Biotechnology, Chemical Engineering – required
• 2 years of experience in pharma in quality roles – required
• High-level Hebrew and English (spoken, reading, and writing) – required
• Fast learner, strong interpersonal communication, ability to lead end-to-end tasks, drive processes forward, and work in parallel (multi-tasking)
• Experience and ability to work with multiple interfaces/stakeholders (internal and external)
• Experience in biological drugs and blood products – significant advantage

The CMO is based in Canada.