Quality, Engineering & Computerized Systems Leader

Kamada is a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions. As a leader in the specialty plasma-derived field, we focus on diseases with limited treatment alternatives, offering 6 FDA-approved products sold in over 30 countries.

Join us in a key, impactful role within Quality, Engineering, and Computerized Systems. This central position acts as a primary interface between the Quality, Engineering, and IT departments, with professional responsibility for validation, control, and change processes in a highly regulated environment.

Key Responsibilities:

• Approve validation documents for computerized systems, process control systems, and engineering systems (URS, VP, FS, TRM, STR, STD, STP, IQ, OQ, PQ)
• Approve validation activities and changes for computerized applications (hardware and software), equipment, and infrastructure
• Review and approve procedures and protocols
• Support the development of policies for computerized systems and software, including Risk Assessment management and GAP Analysis
• Participate in evaluating new software, defining GMP requirements, and establishing user requirements
• Oversee change control processes in control systems, computerized systems, and engineering on behalf of QA
• Support engineering projects as a Quality representative
• Review, manage, and approve validation deviations on behalf of QA

Requirements:

• Bachelor’s degree in Engineering or Sciences – required
• High level of Hebrew and English – required
• Experience writing validation documents for computerized systems – required
• Ability to work with multiple stakeholders and lead processes in a cross-functional environment
• Experience in the pharmaceutical or medical device industry – strong advantage
• Familiarity with GMP Annex 11 and 21 CFR Part 11 – advantage
• Experience collaborating with IT departments (infrastructure, applications, ERP systems)

Full-time position at the company site in Beit Kama