Quality Control Manager.

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