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QA Director - ADL2 Drug Product Operations - Job Opportunity at Amgen

Dún Laoghaire, Ireland
Full-time
Executive
Posted: January 21, 2025
On-site
EUR 150,000 - 200,000 annually based on Dublin biotech market and executive QA role scope

Benefits

Advanced professional development through biotech leadership
Opportunity to shape new facility development
Competitive biotechnology industry compensation package
Career advancement in global pharmaceutical leader
Participation in cutting-edge drug development programs

Key Responsibilities

Lead quality strategy and oversight for new aseptic manufacturing facility development
Establish and manage quality assurance team for drug product operations
Direct GMP compliance and regulatory interactions
Drive quality culture and continuous improvement initiatives
Oversee facility qualification and validation processes
Manage cross-functional collaboration with manufacturing, engineering, and regulatory teams

Requirements

Education

Degree required, B.Sc. in Science, Engineering or equivalent with additional qualifications (Masters/PhD preferred)

Experience

Significant relevant experience in biotechnology and aseptic processing

Required Skills

Strong leadership skills cGMP knowledge Aseptic manufacturing expertise Project management Cross-functional collaboration Regulatory compliance Communication and influence skills Technical process improvement Quality systems management

Certifications

Qualified Person eligibility preferred
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Industry Trends

Increasing focus on aseptic manufacturing capacity in Europe due to growing biologics pipeline Rising demand for sterile injectable manufacturing expertise as biosimilar market expands Enhanced regulatory scrutiny on aseptic processing driving need for sophisticated quality systems Growing emphasis on automation and digital quality management systems in pharmaceutical manufacturing

Role Significance

Expected to build and lead a team of 15-25 quality professionals based on facility scale and complexity
Executive level position with direct influence on site quality strategy and regulatory compliance. Reports to Executive Director with significant autonomy in decision-making.

Key Projects

New facility design and qualification program Quality systems establishment and optimization Regulatory strategy development and implementation Team building and cultural development Process validation and technology transfer

Success Factors

Strong understanding of both technical and regulatory aspects of aseptic manufacturing Ability to build and develop high-performing quality teams Strategic thinking with practical implementation skills Excellence in stakeholder management and communication Track record of successful regulatory interactions

Market Demand

Very High - Critical shortage of experienced QA directors in aseptic manufacturing sector, particularly in Ireland's growing biotech hub

Important Skills

Critical Skills

Aseptic processing expertise - fundamental for sterile drug product manufacturing Quality systems leadership - essential for maintaining regulatory compliance Strategic thinking - crucial for facility development and long-term success People leadership - vital for building and developing effective teams

Beneficial Skills

Digital quality systems experience Lean six sigma methodology Change management expertise Risk-based decision making approaches

Unique Aspects

Opportunity to build quality systems from ground up in new facility
Combination of strategic leadership and hands-on technical involvement
Critical role in major facility expansion project
Significant influence on site quality culture development

Career Growth

3-5 years in role before progression to next level, depending on business growth and performance

Potential Next Roles

VP of Quality Quality Site Head Global Quality Leadership Role Operations Director

Company Overview

Amgen

Amgen is a global biotechnology leader with a strong focus on innovative protein-based therapies and a robust pipeline of biosimilars and novel biologics

Top-tier biotechnology company with significant market presence and strong financial performance
Strategic European manufacturing hub with significant investment in Irish operations
Innovation-driven environment with strong emphasis on scientific excellence and patient focus
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