Director of Quality Assurance

Phibro is seeking an experienced Quality Director -Vaccines to lead all Quality functions at our vaccines manufacturing site in Beit Shemesh.

This senior leadership role is a member of the site leadership team and is responsible for GMP compliance, regulatory readiness, and end‑to‑end quality oversight, ensuring the consistent production of safe, effective, and high‑quality vaccines. The position plays a critical role in protecting Phibro’s license to operate and its reputation with regulators, customers, and global partners.

Key Responsibilities:

Leadership & People Management

• Lead, develop, and inspire QA, QC, and Compliance teams, including managers and team leaders
• Define clear responsibilities, expectations, and performance standards
• Build and sustain a proactive quality culture grounded in GMP expertise, coaching, and problem solving
• Drive talent development, succession planning, and competency‑based training programs

Quality Strategy & Systems

• Define and implement Quality Policy, procedures, and systems aligned with EU GMP and applicable regulatory frameworks
• Own and oversee the Quality Management System (deviations, CAPA, change control, risk management, continuous improvement)
• Ensure data integrity and compliant execution across quality and manufacturing operations

Regulatory Compliance & Audits

• Lead and manage regulatory inspections and audits
• Ensure timely and effective resolution of audit findings, including CAPA planning and execution
• Monitor regulatory updates and ensure procedures and systems remain current

Batch Release & Quality Oversight

• Oversee batch release activities and compliant product disposition
• Review and approve critical manufacturing and QC documentation
• Ensure all release decisions meet regulatory and internal quality standards for vaccines manufacturing

Cross‑Functional Collaboration

• Act as the Quality representative on the Site Leadership Team
• Partner with Manufacturing, Engineering, Regulatory Affairs, R&D, Supply Chain, and TSA to manage quality risks and drive operational improvements
• Integrate quality and regulatory considerations early into decision‑making processes

Quality Oversight of QC & Animal House

• Ensure QC operations meet testing, validation, equipment qualification, and compliance requirements
• Provide quality and regulatory oversight of the Animal House, including animal welfare and testing standards

Vaccines Quality & Product Lifecycle

• Lead investigations (deviations, complaints, OOS), ensuring timely closure and robust root cause analysis
• Drive continuous improvement of product robustness and quality systems
• Monitor scientific and regulatory developments and implement site‑level updates accordingly

GLP Studies & R&D Support

• Provide quality oversight for GLP studies supporting vaccine development
• Ensure compliance with GLP, data integrity, and regulatory expectations
• Support R&D through quality input to study design and method transfer to QC and manufacturing

Qualifications & Experience:

• Advanced degree in Life Sciences, Pharmacy, Biotechnology, or a related field
• Minimum 10+ years of experience in GMP‑regulated QA leadership roles (vaccines, biologics, or sterile manufacturing preferred)
• Proven experience managing regulatory inspections and interfaces with health authorities
• Strong working knowledge of EU GMP, USP/Ph. Eur., ICH, EMA guidelines, and local regulations
• Demonstrated leadership, communication, and cross‑functional influence skills
• Ability to operate effectively in a global, matrixed environment with complex regulatory landscapes
• Strong problem‑solving skills and risk‑based decision‑making approach
• Experience with digital quality systems (e.g., Veeva, LIMS, electronic QMS) and data integrity principles
• Languages: English – high level | Hebrew – fluent