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QA Validation Lead - Job Opportunity at Grifols Worldwide Op Ltd

Dublin, Ireland
Full-time
Senior
Posted: April 10, 2025
On-site
EUR 85,000 - 110,000 per year based on Dublin market rates for senior QA roles in pharma

Benefits

Industry-competitive pension scheme with matched contributions up to 7%, indicating strong retirement focus
Private medical insurance for employee, reflecting commitment to healthcare benefits
Education allowance supporting professional development and career growth
Wellness and social activities including organized sports and events, promoting work-life balance
Career development opportunities in expanding environment
Internal promotion pathways through succession planning

Key Responsibilities

Strategic leadership of QA validation programs including policy development and regulatory compliance oversight
Cross-functional management of validation processes across commercial and clinical manufacturing operations
Regulatory agency liaison including data presentation to HPRA, FDA and other authorities
Budget and resource management for QA validation department
Technical oversight of equipment, utilities, software qualification and validation processes
Development and implementation of validation strategies aligned with business objectives
Personnel management including hiring, performance evaluation, and professional development

Requirements

Education

B.Sc Degree in Life Sciences, Chemistry or Engineering

Experience

5 years experience in quality or production within biological/aseptic pharmaceutical

Required Skills

Excellent communication skills Strong technical writing skills Competence in Microsoft packages Good organizational skills Flexibility Results oriented Decision-making ability Project management capabilities Deep knowledge of aseptic regulatory requirements Technical expertise in biopharmaceutical manufacturing Direct people management
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Sauge AI Market Intelligence

Industry Trends

Increasing regulatory scrutiny in aseptic manufacturing is driving demand for validation expertise, particularly with the recent updates to EU GMP Annex 1 Digital transformation in pharma manufacturing is creating need for validation professionals with both traditional and digital system qualification experience Growing focus on continuous manufacturing processes requires new validation approaches and expertise

Role Significance

Typically manages 5-8 direct reports in validation team with matrix responsibility across multiple departments
Senior leadership position with direct impact on product quality and regulatory compliance

Key Projects

Implementation of new equipment and process validation programs for commercial manufacturing Regulatory authority inspection preparation and management Development and execution of validation master plans Cross-functional process improvement initiatives

Success Factors

Strong understanding of current regulatory landscape and ability to anticipate future requirements Effective stakeholder management across multiple departments and levels Balance of technical expertise with strategic business acumen Ability to build and develop high-performing technical teams

Market Demand

High demand with significant growth projected due to expanding biopharmaceutical sector in Ireland and stringent regulatory requirements

Important Skills

Critical Skills

Deep understanding of aseptic manufacturing and associated regulations Strategic thinking and business acumen for validation program development Strong leadership and stakeholder management capabilities

Beneficial Skills

Knowledge of emerging validation technologies and computerized system validation Experience with continuous improvement methodologies Understanding of global regulatory requirements beyond EU/FDA

Unique Aspects

Role combines traditional validation expertise with emerging technologies in biopharmaceutical manufacturing
Position offers exposure to both commercial and clinical manufacturing operations
Opportunity to influence validation strategies in a growing global healthcare company

Career Growth

Typical progression to director level within 3-5 years with demonstrated success

Potential Next Roles

Quality Director Validation Director Head of Technical Operations Site Quality Head

Company Overview

Grifols Worldwide Op Ltd

Global healthcare company with over 100 years of history, specializing in plasma-derived medicines and transfusion medicine

Industry leader in plasma products with strong market position across 110+ countries
Strategic location in Dublin's Grange Castle hub, positioning the role within Ireland's growing biopharma sector
International environment with emphasis on innovation and professional development
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