Quality Control Manager

Univet Limited; Cootehill; On-site; EUR 90,000 - 130,000; Full time

Job summary

Univet Limited in Ireland seeks a Quality Control (QC) Manager to lead the QC function, ensuring GMP-compliant testing and release of veterinary medicines. You will drive data integrity, regulatory readiness, and continuous improvement across the laboratory.

You will provide technical leadership to the analytical team, oversee testing of raw materials, in-process and finished products, and support inspections and CAPA programs while prioritising patient safety and product quality.

Qualifications

• Degree in Chemistry, Pharmaceutical Sciences or related discipline with GMP knowledge.
• 10+ years in GMP pharmaceutical QC labs; leadership experience.
• Experience with OOS/OOT investigations and CAPAs.
• Proven track record in regulatory inspections and data integrity.

Responsibilities

• Lead and develop the QC team to meet departmental objectives.
• Oversee chemical/analytical testing of raw materials, in-process, finished and stability samples; ensure on-time release.
• Drive continuous improvement and efficiency without compromising quality or compliance.
• Support regulatory inspections and supplier/audit activities.

Skills

Quality leadership

GMP/compliance

HPLC

Data integrity

OOS/OOT investigations

Cross-functional collaboration

Regulatory inspections

Education

Chemistry/Pharmaceutical Sciences degree

Tools

Empower 3

QMS

ELN / eLIMS

Job description

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
• 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
• FTIR
• Dissolution
• pH
• Physical testing
• Provide scientific oversight for:
• Method troubleshooting
• Method validation
• Method transfer
• Method verification

Electronic Quality Systems

• Extensive experience using electronic quality systems including:
• Empower 3 Chromatography Data System
• Electronic Laboratory Documentation
• 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
• Lead and technically review investigations including:
• Out of Specification (OOS)
• Out of Trend (OOT)
• Laboratory Deviations
• CAPAs
• Change Controls
• Laboratory Error Investigations
• Responsibilities include:
• Identification of Corrective and Preventive Actions
• Effectiveness Checks
• Presentation of investigation outcomes to senior management

Regulatory Compliance

• Maintain laboratory compliance with:
• EU GMP
• Veterinary GMP
• VICH Guidelines
• HPRA
• EMA
• Support:
• Regulatory inspections
• Internal audits
• Supplier audits where required
• Act as laboratory subject matter expert during inspections.
• Identify opportunities to improve:
• Laboratory productivity
• Turnaround times
• Testing efficiency
• Laboratory workflow
• Automation opportunities
• Champion Lean principles and continuous improvement initiatives.

Cross-Functional Collaboration

• Work closely with:
• Quality Assurance
• Manufacturing
• Regulatory Affairs
• Supply Chain
• Validation
• Technical Services
• Provide scientific support for manufacturing investigations and product quality issues.
• Balance laboratory performance with business needs by:
• Supporting on-time product release
• Managing laboratory resources efficiently
• 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.
• Minimum10 years’ experiencewithin a GMP pharmaceutical Quality Control laboratory.
• Minimum5 years in a laboratory leadership or management role.
• Experience within veterinary pharmaceuticals is highly desirable.
• 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+
• Analytical Method Validation
• Instrument Qualification
• Stability Programmes
• Laboratory investigations
• CAPA systems

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.
• 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.
• Leadership
• Decision Making
• Scientific Judgement
• Problem Solving
• Regulatory Compliance
• Customer Focus
• Planning & Organisation
• 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