Quality Assurance (QA) Operation Manager

תיאור תפקיד

We're hiring a Quality Assurance (QA) Operation Manager for our Beit Shemesh site, reporting to Global Vaccines Quality Director.
Essential Roles and Responsibilities:
•    Actively participate in daily quality operations, ensuring real-time support for Manufacturing, QC, and Compliance teams (Hand-on).
•    Develop, and retain talent in QA, ensuring the team possesses the right GMP expertise, problem-solving skills, and risk-based decision-making capabilities. 
•    Provide coaching, training, and mentorship to embed a culture of proactive quality ownership.
•    Support regulatory audits and inspections. 
•    Develop, improve, and monitor Quality Systems to ensure compliance with EU GMP and Israel Veterinary Services regulations. 
•    Oversee deviation management, approve CAPAs, and drive continuous improvement. 
•    Write, review, and revise Standard Operating Procedures (SOPs). 
•    Provide quality oversight during active processes, ensuring adherence to regulatory and internal standards. 
•    Identify and correct weaknesses, procedural gaps, and policy exceptions to optimize quality control and assurance. 
•    Provide training to employees on quality procedures and compliance. 
Collaborate with vendors, contractors, and suppliers to ensure they meet the organization's quality standards.
Job requirements:
•    Prior experience interfacing with and managing inspections performed by regulatory bodies.
•    Advanced degree in Life Sciences, Pharmacy, Biotechnology, or a related field. 
•    10+ years of experience in leadership roles within a GMP-regulated biologics, vaccines, or sterile manufacturing environment. 
•    Expertise in EU GMP, regulatory inspections, risk-based QA strategies, and digital transformation in quality systems. 
•    Proven ability to lead teams, optimize QA processes, and drive a culture of continuous improvement.
•    Strong working knowledge of Industry Compendia, regulations, and standards including USP / Ph. Eur, GMP, EMA, and ICH
•    High-level English required, Hebrew fluency.