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Biotech QA Manager - Job Opportunity at JobContax

Dún Laoghaire, Ireland
Contract
Senior
Posted: May 14, 2025
Remote
EUR 55-63 per hour

Benefits

Remote work flexibility
Limited travel requirements
Quarterly onsite visits
12-month minimum contract duration
European travel opportunities

Key Responsibilities

Quality and compliance oversight of contract labs and CMOs
Cross-functional team leadership in manufacturing operations
Regulatory inspection management and preparation
Quality agreement negotiation and approval
Batch disposition and release authority
GMP compliance strategy development
Master batch record review and approval
Quality system management including deviations, CAPA, and change controls

Requirements

Education

Doctorate degree & 2 years experience OR Master's degree & 4 years experience OR Bachelor's degree & 6 years experience

Experience

10+ years biotech or pharmaceutical industry experience

Required Skills

Aseptic manufacturing expertise Senior stakeholder management Project management Strategic decision-making Cross-functional team leadership Quality systems management Regulatory compliance GMP knowledge Deviation management Change control CAPA management Risk assessment Technical documentation Regulatory inspection experience
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on contract manufacturing oversight in biotech sector Growing importance of remote quality management systems Rising demand for expertise in aseptic manufacturing processes Expansion of regulatory compliance requirements in European biotech manufacturing

Salary Evaluation

The offered rate of €55-63 per hour (approximately €114,400-131,040 annually) aligns with senior QA management roles in the Irish biotech sector, reflecting the high-level responsibilities and extensive experience requirements

Role Significance

Likely leading a quality team of 5-10 professionals while coordinating with multiple cross-functional teams
Senior management position with significant autonomy and strategic decision-making authority in quality assurance

Key Projects

Regulatory inspection preparation and management Quality system optimization Contract manufacturer oversight Process validation activities Compliance strategy development

Success Factors

Strong understanding of EU GMP requirements and regulatory landscape Ability to work independently while managing multiple stakeholders Excellence in risk assessment and mitigation Strategic thinking combined with tactical execution capabilities Strong decision-making abilities in complex quality scenarios

Market Demand

High demand position due to expanding biotech manufacturing presence in Ireland and increasing regulatory complexity

Important Skills

Critical Skills

Aseptic manufacturing expertise - essential for product quality and compliance Regulatory knowledge - crucial for inspection management and compliance Strategic thinking - vital for quality system optimization and risk management

Beneficial Skills

Additional European languages Experience with multiple regulatory bodies Knowledge of emerging biotech manufacturing technologies

Unique Aspects

Fully remote position in a traditionally on-site role
Combination of strategic oversight and hands-on quality management
Opportunity to influence quality systems in a growing operation

Career Growth

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

Potential Next Roles

Head of Quality Quality Director VP of Quality Global Quality Lead

Company Overview

JobContax

Leading international biotechnology company with significant investment in Irish operations

Major player in biotech manufacturing with state-of-the-art aseptic facilities
Strategic European manufacturing hub with significant growth trajectory
Dynamic, fast-paced environment with emphasis on autonomy and expertise
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