QA Manager – Validation and Change Control

Description:

• Full responsibility for laboratory management, including resource and budget management, project oversight, and long-term strategic planning.
• Managerial responsibility for implementing GMP principles and ensuring regulatory compliance in the laboratories, in accordance with company procedures and the parent company’s policies.
• Accountability for aligning laboratory operations with the company’s quality management system and business objectives.
• Responsibility for setting policies regarding laboratory testing.
• Oversight of laboratory investigations, change controls, CAPA, SOPs, protocols and reports, and deviations.
• Responsibility for the professional and personal development of lab employees.
• Ensuring employee proficiency in aspects of quality, safety, and operations.
• Responsibility for the certification and training of the chromatography lab team for all relevant activities.
• Responsibility for lab team safety.
• Participation in and representation of the laboratory during regulatory audits.

Requirements:

• Bachelor's degree or higher in Life Sciences, Chemistry, Biotechnology, or related fields.
• Previous experience in a pharmaceutical laboratory environment operating under GMP conditions.
• Expertise in chromatography and hands-on experience with HPLC/UPLC/GC/MS systems.
• Familiarity and previous experience with Waters systems and EMPOWER software – an advantage.
• Knowledge of pharmacopoeias and regulatory requirements related to chromatography; experience with validations and analytical method transfers.
• Experience with LIMS systems – an advantage.
• Experience in chromatography of biological products and proteins – an advantage.
• Strong leadership, organizational, and team management skills.
• 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).