QC External Lab Coordinator - Job Opportunity at Regeneron

County Limerick, Ireland
Full-time
Mid-level
Posted: February 11, 2025
On-site
EUR 45,000 - 65,000 annually based on Irish pharmaceutical industry standards and role complexity

Benefits

Comprehensive healthcare and wellness programs
Fitness center access
Competitive annual leave package
Annual bonus potential
Equity awards
Professional development opportunities

Key Responsibilities

Strategic coordination of sample management and method transfer activities for external laboratories
Quality system management and LIMS data integrity oversight
Contract laboratory relationship management and Quality Agreement administration
GMP audit participation and compliance verification
Technical troubleshooting and validation oversight
Laboratory investigation management and CAPA execution

Requirements

Education

BSc degree or higher in biology, chemistry, microbiology or related field

Experience

Relevant experience preferably in pharmaceutical or biotechnology industries

Required Skills

Problem-solving abilities Strong interpersonal skills Adaptability Continuous learning mindset GMP regulatory knowledge Laboratory method transfer expertise Quality system management Technical troubleshooting Investigation management
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Industry Trends

Increasing externalization of laboratory testing services in biopharma driving demand for coordination roles Growing focus on data integrity and digital sample tracking systems in regulated environments Rising importance of strategic supplier management in pharmaceutical quality operations

Role Significance

Typically part of a 5-10 person QC team interfacing with multiple external laboratories
Mid-level technical specialist role with significant impact on quality operations and regulatory compliance

Key Projects

Method transfer validation programs External laboratory qualification initiatives Quality system enhancement projects Compliance audit preparation and execution

Success Factors

Strong technical background combined with excellent project management capabilities Ability to navigate complex regulatory requirements while maintaining operational efficiency Excellence in relationship management with external partners Strategic problem-solving skills with focus on compliance and quality

Market Demand

High demand role due to increasing regulatory requirements and growing outsourcing trends in pharmaceutical testing

Important Skills

Critical Skills

GMP regulatory knowledge - Essential for ensuring compliance and quality standards Project management - Critical for coordinating complex method transfers and external lab activities Technical expertise - Fundamental for troubleshooting and method validation oversight

Beneficial Skills

Digital systems expertise - Growing importance with increasing LIMS adoption Change management skills - Valuable for process improvement initiatives Risk assessment capabilities - Important for supplier management and quality decisions

Unique Aspects

Strategic position bridging internal quality operations with external testing networks
High impact on regulatory compliance and product quality assurance
Combination of technical expertise and relationship management requirements

Career Growth

2-4 years in role typically required before advancement to management positions

Potential Next Roles

QC Manager Quality Systems Manager Laboratory Operations Manager Supplier Quality Manager

Company Overview

Regeneron

Regeneron is a leading biotechnology company focused on developing life-transforming medicines

Major player in the global biotech sector with strong market presence and innovative pipeline
Significant investment in Irish operations as part of European expansion strategy
Innovation-driven environment with strong focus on scientific excellence and professional development
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