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:
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:
Responsibilities include:
Regulatory Compliance
Maintain laboratory compliance with:
Support:
Act as laboratory subject matter expert during inspections.
Continuous Improvement
Identify opportunities to improve:
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:
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
