Job Description

Quality Manager - Veterinary Pharmaceuticals

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Kato Laboratories is an Australian owned veterinary pharmaceutical manufacturer committed to the research, development and manufacture of high-quality animal health products for domestic and international markets. Our manufacturing operations comply with GMP requirements and international regulatory standards. Kato is staffed by a small team of skilled professionals.

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About the role

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We are seeking an experienced Quality Manager to oversee our Quality Assurance and Quality Control functions; ensuring compliance with GMP requirements across the manufacture of veterinary pharmaceutical products; & maintaining regulatory compliance with APVMA, FDA, EMA and international quality standards.

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Lead the site's Quality Management System (QMS).

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Monitor GMP compliance throughout manufacturing and laboratory operations for veterinary pharmaceutical manufacturing.

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Manage quality assurance procedures ensuring integrity, security and traceability of quality data and records including:

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- Document Control
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- Batch Release
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- CAPA
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- Deviations
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- Change Control
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- Product Quality Reviews
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Analyse quality data and metrics to identify trends, areas for improvement, and corrective actions.

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Lead investigations into quality issues and non-conformance, determining root causes and implementing preventive measures.

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Review and approve validation protocols including:

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- Process Validation
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- Cleaning Validation
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- Equipment Qualification
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- Release of Stability Studies and Batch Manufacture documentation.
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Establish, document, validate and implement all Quality Control test procedures including sampling, testing, retention samples.

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Conduct in-house quality audits to ensure compliance with APVMA, VICH,



PIC/S, FDA and EMA expectations where applicable.

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Represent Kato for health authority audits (APVMA/TGA); responsibility for audit documentation and GMP licence of facility.

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Mentor and develop staff in QA/QC and continuous improvement methodologies.

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Monitor supplier and vendor quality performance to maintain supply chain integrity.

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Report on quality metrics and performance indicators to management.

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Essential Qualifications

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- Bachelor degree: Pharmacy, Chemistry, Pharmaceutical Science or related discipline.
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- Minimum 5-10 years within pharmaceutical or veterinary pharmaceutical industry
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- Minimum 3-5 years in a Quality Management role.
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- Quality Assurance and Quality Systems management.
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- Leadership skills & ability to mentor and train team members toward a strong quality culture.
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- Excellent problem-solving abilities and a high attention to detail.
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- Strong communication and interpersonal skills.
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- Proficiency with documentation systems and management of complex quality records.
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- Excellent technical writing and documentation skills.
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- A proactive approach to continuous improvement and commitment to maintaining the highest quality standards.
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- Regulatory compliance and audit readiness: APVMA, TGA and European regulatory.
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- Strong working knowledge of: PIC/s GMP; APVMA Manufacturing Principles; VICH Guidelines: ICH Q7; FDA, cGMP requirements; EU GMP; ISO Quality Systems.
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What we offer

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At Kato Laboratories, we value our employees and offer a supportive and friendly work workplace that promotes career development and work-life balance. We foster a collaborative culture where your contributions are valued, and we encourage innovation and continuous learning.

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part-time (2xdays per week) role.

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📌 Quality Manager - Veterinary Pharmaceuticals (Central Coast Council)
🏢 Kato Laboratories
📍 Central Coast Council