Director of Quality Assurance

COMPANY OVERVIEW

Phibro Animal Health Corporation (PAHC) is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals. Phibro is a diversified company. In addition to animal nutrition and health, we manufacture and market products for ethanol performance, microbials for plants, home and industrial applications, and specialty chemicals for various industrial markets. Phibro’s revenues are in excess of $1 billion and are supported by over 2,300 employees worldwide.

PURPOSE OF THE JOB

1. The Quality Director – Vaccines leads all Quality functions at the Beit Shemesh vaccines manufacturing site, ensuring GMP compliance, regulatory readiness, and consistent production of safe, effective, high‑quality vaccines. The role shapes quality culture, drives risk management, enables operational excellence, and safeguards Phibro’s license to operate and reputation with regulators, customers, and global partners.

KEY RESPONSIBILITIES:

Leadership & People Management

• Lead and develop QA, QC, and Compliance teams, including managers and team leaders.
• Set clear responsibilities, expectations, and performance standards.
• Build a proactive quality culture grounded in GMP expertise, coaching, and problem‑solving.
• Develop talent, succession plans, and competency‑based training.

Quality Strategy & Systems

• Define and implement Quality Policy, procedures, and systems aligned with EU‑GMP and IVS regulatory frameworks.
• Oversee QMS (deviations, CAPA, change control, risk management, continuous improvement).
• Ensure data integrity and compliant execution across production and quality functions

Regulatory Compliance & Audits

• Manage regulatory inspections.
• Address audit findings promptly, including CAPA planning and execution.
• Stay informed on regulations and update procedures accordingly.

Batch Release & Quality Oversight

• Oversee batch release processes and ensure compliant product disposition.
• Review and approve critical manufacturing and QC documentation.
• Ensure disposition decisions meet regulatory and internal standards for vaccines manufacturing.

Cross‑Functional Collaboration & Decision Support

• Serve as the Quality representative on the site Leadership Team.
• Partner with RA, R&D, Manufacturing, Engineering, Supply Chain, and TSA to manage quality risks and operational improvements.
• Ensure quality considerations and regulatory implications are integrated early into decision‑making processes.

Quality Oversight of QC & Animal House

• Ensure QC operations meet testing, validation, equipment qualification, and compliance requirements.
• Oversee the Animal House facility to ensure appropriate welfare, testing quality, and regulatory compliance.

Vaccines Quality & Product Lifecycle

• Lead investigations (deviations, complaints, OOS), ensuring timely closure and clear root‑cause identification.
• Drive continuous improvement of product robustness and quality systems.
• Monitor scientific and regulatory developments and update site practices accordingly.

GLP Studies & R&D Support

• Provide GLP quality oversight for studies supporting vaccine development.
• Ensure adherence to GLP, data integrity, and regulatory expectations.
• Support R&D by providing quality input to study design and facilitating method transfer to QC/production

KEY COMPETENCIES, REQUIREMENTS, COMPLEXITY

1. Strong leadership, communication, and cross‑functional influence skills.
2. Ability to operate in a matrixed global environment with complex regulatory landscapes.
3. Skilled in problem‑solving, risk‑based decision making, and driving continuous improvement.
4. Excellent time management and ability to perform under pressure.
5. Digital quality systems capability (Veeva, LIMS, electronic QMS) with emphasis on data integrity.

EDUCATION, KNOWLEDGE, YEAR OF EXPERIENCE:

1. Advanced degree in Life Sciences, Pharmacy, Biotechnology, or related field.
2. Minimum 10+ years in GMP‑regulated QA leadership roles (vaccines, biologics, sterile manufacturing preferred).
3. Demonstrated experience managing inspections and regulatory interfaces.
4. Strong working knowledge of EU‑GMP, USP/Ph.Eur, ICH, EMA guidelines, and local regulations.
5. English – high level; Hebrew – fluent.

ADDITIONAL INFORMATION

Impact on Results

• Ensures GMP compliance, protects Phibro’s regulatory licenses, reduces quality and regulatory risk, and supports uninterrupted global vaccine supply.

Accountability & Decision Authority

• Accountable for quality decisions including batch disposition, escalations, and major deviations.
• Approves quality policies, SOPs, and changes with regulatory impact.
• Escalates strategic issues to the Global Vaccines Quality Director as required.

Compliance & GMP Regulatory Exposure

• Full responsibility for EU‑GMP, IVS, and other regulatory bodies’ compliance.
• Oversight of QMS elements including Deviations, CAPA, Change Control, Validation, Data Integrity.

Leadership & People Management

• Direct management of QA, QC, Compliance managers and key technical staff.
• Responsibility for talent development, succession planning, and capability building.

Communication & Influence

• Represents Quality in global and site leadership forums.
• Communicates quality expectations, risks, and compliance status to senior stakeholders.
• Influences cross‑functional teams to strengthen quality culture and alignment.