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Tullyvin, Cootehill, County Cavan, Negotiable Permanent | Full Time Contact name: Univet Position Summary The Quality Control (QC) Manager is responsible for leading the Quality Control function to ensure all testing activities support the manufacture and release of high-quality veterinary medicinal products in compliance with GMP, pharmacopoeial requirements and regulatory expectations. The successful candidate will provide technical leadership to the laboratory, ensuring efficient laboratory operations while maintaining the highest standards of data integrity, scientific excellence and regulatory compliance. They will drive continuous improvement, support regulatory inspections, manage laboratory investigations, and foster a culture where quality and patient safety remain the highest priorities. Key Responsibilities Laboratory Leadership Lead and develop the QC team to achieve departmental objectives. Provide coaching, mentoring and performance management for laboratory personnel. Ensure laboratory resources are effectively allocated to meet manufacturing schedules. Promote a culture of accountability, ownership and continuous improvement. Develop succession planning and staff competency programmes. Laboratory Operations Oversee all chemical and analytical testing including: Raw Materials Packaging Components In-Process Samples Finished Products Stability Samples Environmental Monitoring support where applicable Ensure laboratory testing is completed accurately and within agreed timelines. Drive laboratory efficiency without compromising product quality or regulatory compliance. Monitor KPIs and laboratory performance metrics. Analytical Expertise Demonstrate extensive experience in analytical techniques including: HPLC UPLC UV Spectroscopy FTIR Dissolution Karl Fischer pH Physical testing Pharmacopoeial methods Provide scientific oversight for: Method troubleshooting Method validation Method transfer Method verification Instrument qualification Electronic Quality Systems Extensive experience using electronic quality systems including: Empower 3 Chromatography Data System Electronic Laboratory Documentation LIMS (desirable) Electronic Quality Management Systems (QMS) Data Integrity principles (ALCOA+) Ensure all electronic records comply with: EU GMP Annex 11 21 CFR Part 11 Data Integrity Guidance Company procedures Investigation Management Lead and technically review investigations including: Out of Specification (OOS) Out of Trend (OOT) Laboratory Deviations CAPAs Change Controls Laboratory Error Investigations Responsibilities include: Root Cause Analysis Identification of Corrective and Preventive Actions Risk Assessment Effectiveness Checks Presentation of investigation outcomes to senior management Regulatory Compliance Maintain laboratory compliance with: EU GMP Veterinary GMP VICH Guidelines Pharmacopoeial Requirements HPRA EMA FDA (desirable) Support: Regulatory inspections Customer audits Internal audits Supplier audits where required Act as laboratory subject matter expert during inspections. Continuous Improvement Identify opportunities to improve: Laboratory productivity Turnaround times Testing efficiency Documentation quality Right-first-time performance Laboratory workflow Automation opportunities Champion Lean principles and continuous improvement initiatives. Cross-Functional Collaboration Work closely with: Quality Assurance Manufacturing Engineering Regulatory Affairs Supply Chain Validation Technical Services Provide scientific support for manufacturing investigations and product quality issues. Commercial Awareness Balance laboratory performance with business needs by: Supporting on-time product release Managing laboratory resources efficiently Understanding manufacturing priorities Controlling laboratory expenditure Supporting strategic business objectives Always ensuring that quality, regulatory compliance and patient safety are never compromised. Essential Qualifications Degree in Chemistry, Pharmaceutical Sciences, Analytical Chemistry or related scientific discipline. Minimum 10 years’ experience within a GMP pharmaceutical Quality Control laboratory. Minimum 5 years in a laboratory leadership or management role. Experience within veterinary pharmaceuticals is highly desirable. Essential Experience Minimum 10 years GMP laboratory experience. Extensive experience with Empower 3. Strong HPLC troubleshooting expertise. Experience managing electronic laboratory documentation. Proven experience leading regulatory inspections. Extensive experience managing OOS and laboratory investigations. Experience reviewing analytical data. Experience with method validation and transfer. Strong understanding of Data Integrity. Experience managing laboratory KPIs. Experience leading teams through organisational change. Experience implementing continuous improvement initiatives. Technical Knowledge Strong knowledge of: EU GMP Annex 11 Annex 15 Data Integrity Guidance ALCOA+ Pharmacopoeial testing Analytical Method Validation Instrument Qualification Stability Programmes Laboratory investigations CAPA systems Risk Management (ICH Q9) Personal Attributes The successful candidate will demonstrate: Excellent leadership and people management skills. Strong scientific and analytical thinking. Exceptional attention to detail. High levels of integrity and professionalism. Excellent communication skills. Ability to make balanced, risk-based decisions. Strong organisational skills. Commercial awareness with a pragmatic approach. A collaborative leadership style. The ability to remain calm under pressure. A commitment to continuous improvement. Key Competencies Leadership Decision Making Scientific Judgement Problem Solving Investigation Management Regulatory Compliance Customer Focus Commercial Awareness Planning & Organisation Continuous Improvement Communication Team Development Data Integrity Quality Mindset Success Measures The successful QC Manager will be expected to deliver: Right First Time laboratory performance. Timely completion of analytical testing. Robust and scientifically sound investigations. Successful regulatory inspections. High laboratory compliance standards. Reduced laboratory turnaround times. Continuous improvement in laboratory efficiency. Strong team engagement and development. Excellent cross-functional collaboration. Consistent support of manufacturing while maintaining uncompromising quality standards. Reports To: Head of Quality / Quality Director / Qualified Person | Next Job >> Would you like to apply for this job? 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