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Senior Quality Assurance QA Specialist - 12 Month Contract - Job Opportunity at VLE Therapeutics Ltd

Dublin, Ireland
Contract
Senior
Posted: May 5, 2025
On-site
EUR 75,000 - 95,000 per year based on Dublin market rates for senior QA roles in biotech

Benefits

Equal opportunity employer
Work in cutting-edge biomanufacturing facility
Professional development opportunities in emerging therapeutics sector

Key Responsibilities

Lead QA operations and PQS management with strategic oversight of manufacturing compliance
Drive quality system improvements and risk management aligned with ICH Q9 rev1
Manage QA team and foster high-performance quality culture
Oversee supplier quality management and regulatory compliance
Direct quality assurance for manufacturing operations and material management

Requirements

Education

Primary Degree in scientific discipline or equivalent

Experience

At least 5 years' experience in cGMP Pharmaceutical Operations

Required Skills

Quality systems expertise GMP knowledge Decision-making skills Staff management experience Quality Risk Management Good Distribution Practice Supplier Quality Management
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Sauge AI Market Intelligence

Industry Trends

The biologics and advanced therapeutics manufacturing sector is experiencing rapid growth, particularly in Ireland as a key European hub Increasing focus on digital integration and single-use technologies in biomanufacturing reflects industry modernization Growing demand for local supply chain solutions in vaccine and biologics production within Europe

Role Significance

Likely managing 2-4 direct reports in QA function within a broader quality department of 10-15 people
Senior strategic position with direct management responsibilities and significant influence on quality systems development

Key Projects

Implementation of new quality management systems for greenfield facility Development of supplier quality management program Regulatory inspection readiness and compliance programs Digital quality system transformation initiatives

Success Factors

Strong technical expertise in GMP and quality systems Leadership capability in developing high-performance quality culture Strategic thinking in quality risk management Ability to influence cross-functional stakeholders Experience in new facility qualification and validation

Market Demand

Very High - Driven by expansion of biologics manufacturing capacity in Ireland and European focus on supply chain sovereignty

Important Skills

Critical Skills

GMP compliance expertise - essential for regulatory compliance and operational excellence Quality risk management - key for new facility setup and operations Leadership skills - critical for developing quality culture and team capabilities

Beneficial Skills

Digital quality system experience Project management capabilities Understanding of single-use technology applications in biologics manufacturing

Unique Aspects

Opportunity to shape quality systems in new facility development
Combination of established company backing with startup growth potential
Strategic role in Ireland's emerging biologics manufacturing capability

Career Growth

2-4 years potential progression to next level, depending on business growth and performance

Potential Next Roles

Quality Director Head of Quality Quality Operations Leader Qualified Person (with additional certification)

Company Overview

VLE Therapeutics Ltd

New Irish-owned venture in advanced therapeutics manufacturing, emerging from established process development company APC Ltd

Early-stage but strategically positioned in high-growth biologics manufacturing sector
Significant potential to become key player in European biologics manufacturing landscape
Dynamic startup environment within established pharmaceutical industry framework, emphasis on innovation and quality excellence
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