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External Supply QA Manager - Job Opportunity at Amgen

Dún Laoghaire, Ireland
Full-time
Senior
Posted: August 8, 2025
Hybrid
EUR 85,000 - 120,000 per year, based on the senior-level responsibilities, specialized pharmaceutical quality expertise required, and Ireland's competitive biotechnology market. The role's strategic importance in managing external manufacturing relationships and regulatory compliance typically commands premium compensation in the pharmaceutical sector.

Key Responsibilities

Lead quality oversight and compliance management for Contract Manufacturing Organizations (CMOs) ensuring alignment with Clinical Trial Applications and Marketing Authorization requirements
Serve as the primary quality representative within cross-functional contract manufacturing teams, driving strategic alignment across business operations, analytical science, process development, and supply chain functions
Manage critical quality communications and issue resolution with both internal stakeholders and external manufacturing partners, ensuring rapid escalation and resolution of quality concerns
Oversee comprehensive quality documentation approval processes including deviations, change controls, CAPAs, and batch dispositions for all Amgen products manufactured externally
Ensure CMO compliance with contractual quality obligations, Amgen specifications, and all applicable quality, safety, and regulatory requirements through proactive monitoring and management
Execute quality oversight of manufacturing operations, testing protocols, and product release activities at external manufacturing sites to ensure consistent product quality
Lead regulatory inspection preparedness and represent Amgen during product-specific regulatory inspections and Notified Body audits at CMO facilities
Drive risk identification and mitigation strategies at CMO and testing laboratory sites, implementing corrective measures to prevent quality issues
Support critical business activities including New Product Introductions, technology transfers, Process Performance Qualifications, and regulatory filings at external manufacturing sites
Manage international market expansion activities and submission-related processes at CMOs to support global product launches and market access initiatives

Requirements

Education

Doctorate degree OR Master's degree & 2 years of directly related experience OR Bachelor's degree & 4 years of directly related experience OR Associate's degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience

Experience

4+ years of quality and manufacturing experience in biotech or pharmaceutical industry

Required Skills

cGMP Experience Ability to oversee multiple projects simultaneously Able to successfully manage workload to timelines Familiarity with basic project management tools Ability to negotiate a position after taking feedback from multiple sources Demonstrated ability to consistently deliver on-time, and high-quality results Ability to operate in a matrixed or team environment Ability to manage diverse relationships Ability to lead and manage cross-functional teams Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Ability to travel +/- 20% of time to domestic and international Amgen/External sites
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Industry Trends

The pharmaceutical industry is experiencing unprecedented growth in outsourced manufacturing, with over 70% of biopharmaceutical companies now relying on Contract Manufacturing Organizations for critical production activities. This trend is driven by the need to reduce capital expenditure, access specialized expertise, and accelerate time-to-market for new therapies. External Supply QA roles have become increasingly strategic as companies must maintain quality standards while managing complex supplier networks across multiple geographies. Regulatory agencies worldwide are intensifying their focus on supply chain integrity and quality oversight of contract manufacturing operations. Recent FDA guidance documents emphasize the sponsor company's ultimate responsibility for product quality, regardless of where manufacturing occurs. This has elevated the importance of roles like External Supply QA Manager, who serve as the critical link between pharmaceutical companies and their manufacturing partners. The biotechnology sector is experiencing rapid consolidation and expansion into emerging markets, creating complex quality challenges for companies managing global supply chains. Ireland's position as a European hub for pharmaceutical manufacturing, combined with its skilled workforce and favorable regulatory environment, makes it an attractive location for companies seeking to manage European and international supply operations.

Role Significance

Typically manages a team of 3-8 quality professionals and coordinates with cross-functional teams of 15-25 members across various disciplines. The role involves direct oversight of quality activities at multiple external sites, requiring coordination with dozens of CMO personnel and internal stakeholders across different business units and geographical regions.
This is a senior-level position with significant decision-making authority, including the power to approve or reject batch releases and external site changes. The role operates at a strategic level within the organization, serving as the primary interface between Amgen and its contract manufacturing partners. The breadth of responsibilities, from regulatory representation to cross-functional team leadership, indicates this position sits within the upper management tier of the quality organization.

Key Projects

Leading technology transfer initiatives for new product launches at contract manufacturing sites Managing regulatory filing activities and inspection preparedness across multiple international markets Implementing quality system improvements and harmonization across the external manufacturing network Supporting merger and acquisition activities involving quality assessment of potential manufacturing partners Driving cost optimization initiatives while maintaining quality standards across the supply chain

Success Factors

Deep understanding of global pharmaceutical regulations and quality standards, with the ability to interpret and apply complex regulatory requirements across different jurisdictions. Success requires staying current with evolving regulatory landscapes and effectively communicating requirements to both internal teams and external partners. Exceptional relationship management and negotiation skills, as the role requires building and maintaining productive partnerships with contract manufacturers while ensuring compliance with Amgen's quality standards. The ability to influence without direct authority and manage conflicts diplomatically is crucial for success. Strong project management and risk assessment capabilities, enabling effective oversight of multiple concurrent manufacturing activities while proactively identifying and mitigating potential quality issues before they impact product supply or patient safety. Technical expertise in biopharmaceutical manufacturing processes and quality systems, combined with the business acumen to balance quality requirements with commercial objectives and timelines.

Market Demand

High demand driven by industry outsourcing trends and regulatory complexity. Companies are actively seeking experienced professionals who can navigate the intricate landscape of contract manufacturing quality oversight while ensuring compliance across multiple jurisdictions.

Important Skills

Critical Skills

cGMP expertise is absolutely essential as it forms the foundation of all pharmaceutical manufacturing quality systems. Without thorough understanding of current Good Manufacturing Practices, it would be impossible to effectively oversee contract manufacturing operations or ensure regulatory compliance. This knowledge directly impacts patient safety and product efficacy. Cross-functional team leadership capabilities are critical because this role requires coordinating complex activities across multiple departments, companies, and geographical regions. The ability to influence and align diverse stakeholders toward common quality objectives is fundamental to success in managing external manufacturing relationships. Regulatory compliance knowledge is vital given the role's responsibility for representing Amgen during inspections and ensuring adherence to international quality standards. Deep understanding of regulatory requirements across different markets is essential for maintaining product registrations and market access. Risk assessment and mitigation skills are crucial for proactively identifying potential quality issues before they impact patient safety or product supply. The ability to systematically evaluate and address risks across complex supply chains is fundamental to maintaining consistent product quality.

Beneficial Skills

Advanced project management certifications such as PMP would enhance effectiveness in managing multiple concurrent manufacturing projects and technology transfers. These skills become increasingly valuable as pharmaceutical companies adopt more sophisticated project management methodologies. International business experience and cultural competency would be highly valuable given the global nature of contract manufacturing relationships and the need to work effectively with partners across different cultural contexts and business practices. Digital quality systems expertise is becoming increasingly important as the pharmaceutical industry adopts advanced manufacturing technologies, artificial intelligence, and data analytics to enhance quality oversight and predictive risk management capabilities. Strategic business development skills would be beneficial for contributing to partner selection, contract negotiation, and relationship management activities that extend beyond traditional quality oversight responsibilities.

Unique Aspects

This role offers the distinctive opportunity to work at the intersection of science and business, managing quality relationships with contract manufacturers across multiple continents while ensuring compliance with diverse regulatory requirements. The position provides exposure to cutting-edge biotechnology manufacturing processes and the chance to influence quality standards across Amgen's global supply network.
The strategic nature of this position within Amgen's European operations provides unique visibility into international market expansion activities and regulatory strategy development. The role offers direct involvement in new product launches and the opportunity to shape quality standards for emerging markets.
Working for a leading biotechnology company like Amgen in Ireland positions professionals at the forefront of scientific innovation while benefiting from Ireland's thriving biotechnology ecosystem and favorable business environment.
The role provides extensive international exposure through travel requirements and collaboration with manufacturing partners worldwide, offering valuable experience in managing quality operations across diverse cultural and regulatory environments.

Career Growth

Career progression to director level typically occurs within 3-5 years with strong performance, while advancement to VP level generally requires 5-8 years of demonstrated success in external manufacturing quality management.

Potential Next Roles

Director of External Quality Operations, with expanded responsibility for global contract manufacturing quality strategy Head of Quality Assurance, overseeing both internal and external quality operations across multiple therapeutic areas Vice President of Supply Chain Quality, leading enterprise-wide quality initiatives across the entire supply network Regional Quality Director for Europe, managing all quality operations within the European market Chief Quality Officer at a mid-sized biotechnology company, with comprehensive quality leadership responsibilities

Company Overview

Amgen

Amgen stands as one of the world's leading biotechnology companies, pioneering the development of innovative medicines derived from advances in molecular biology and biochemistry. Founded in 1980, the company has established itself as a global leader in developing, manufacturing, and commercializing human therapeutics based on cellular and molecular biology. With a focus on areas of unmet medical need, Amgen has brought numerous breakthrough therapies to market across oncology, cardiovascular disease, inflammation, bone health, and other therapeutic areas.

As a Fortune 500 company with annual revenues exceeding $25 billion, Amgen maintains a dominant position in the global biotechnology sector. The company consistently ranks among the top biotechnology employers worldwide and is recognized for its scientific innovation, with one of the industry's most robust research and development pipelines. Amgen's strong financial position and established market presence provide stability and growth opportunities for employees in critical roles.
Amgen's Dublin operations represent a significant strategic investment in Europe, serving as a key hub for the company's international manufacturing and supply chain activities. Ireland's favorable regulatory environment, skilled workforce, and strategic location within the European Union make it an ideal base for managing European market access and supply operations. The Dublin facility plays a crucial role in supporting Amgen's global supply chain and serves as a center of excellence for external manufacturing quality oversight.
Amgen fosters a science-driven culture that emphasizes innovation, collaboration, and patient focus. The company is known for its commitment to employee development, offering extensive learning opportunities and career advancement pathways. With a strong emphasis on work-life balance and employee well-being, Amgen consistently ranks among the top employers in the biotechnology sector. The collaborative environment encourages cross-functional partnerships and provides opportunities for high-impact work that directly contributes to improving patient outcomes.
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