QA Manager – Validation and Change Control

Job Description:

• Responsibility for managing team tasks: training, supervision, and coordination of team activities.
• Review and approval of validation processes across multiple domains (equipment, process, cleaning, analytical methods, infrastructure, systems, cleanrooms, computerized systems).
• Management of change controls and quality records (deviations, CAPA).
• Authoring protocols and reports for process and cleaning validation.
• Performing risk assessments and providing ongoing support for projects.
• Writing and approving procedures in accordance with relevant standards.
• Participation in regulatory inspections, internal audits, and supplier audits.
• Leading quality improvement initiatives.
• This position is open to all genders.

Requirements:

• Bachelor’s degree or higher in one of the following fields: Biotechnology Engineering, Chemical Engineering, Pharmaceutical Engineering, Biomedical Engineering, Chemistry, Biochemistry, Biotechnology, Life Sciences, or Pharmacy.

• Professional Experience: At least 5 years of managerial experience – required.

• Experience in the pharmaceutical industry in a GMP environment – required.
• Extensive experience in authoring, reviewing, and approving validation processes (equipment, process, cleaning, infrastructure) – required.
• Experience in managing change controls and quality records – required.
• Experience in writing SOPs, protocols, and reports.
• Experience in leading and participating in regulatory inspections.

Skills:

High proficiency in English (reading, writing, speaking).

• Excellent interpersonal skills and the ability to work in a dynamic, cross-functional environment.
• Excellent presentation and communication skills, both verbal and written, in Hebrew and English.
• Strong interpersonal skills and ability to work effectively with cross-functional teams.
• High-level proficiency in English (spoken and written).