PHARMAFull-time
Sr. Manager Manufacturing Support - Deviations
DUBLIN (IE)HYBRIDPOSTED: 8/10/2026
PHARMAFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
ROLE DEFINITION & RESPONSIBILITIES
Manage the manufacturing deviations team for Amgen Dun Laoghaire (ADL), providing operational leadership for the Vial and Syringe manufacturing suites.
Direct the investigation, root cause analysis, and resolution of manufacturing deviations to ensure compliance with cGMP, FDA, and global regulatory guidelines.
Lead, mentor, and develop a team of deviation investigators, fostering a culture of safety, quality, diversity, and operational excellence.
Oversee the implementation of robust Corrective and Preventive Actions (CAPA) and lead continuous improvement initiatives to minimize process deviations.
Collaborate with cross-functional stakeholders in Quality Assurance, Production, Engineering, and Regulatory Affairs to maintain audit readiness and resolve complex quality issues.
Maintain comprehensive documentation for deviation lifecycles and present status reports, trend metrics, and risk assessments to senior leadership.
REQUIRED VERIFIED SKILLS
Deviation Management
Root Cause Analysis
CAPA
Quality Assurance
GMP / FDA Regulations
Team Leadership
Process Improvement
Audit Readiness
Risk Assessment
COMPENSATION & REWARDS
EUR 1.0L - 1.3L per annum
ORGANIZATION CONTEXT & CULTURE
Amgen is a leading global biopharmaceutical company committed to unlocking the potential of biology for patients suffering from serious illnesses. It discovers, develops, manufactures, and delivers innovative human therapeutics, focusing on areas with high unmet medical needs such as oncology, cardiovascular disease, bone disease, and inflammatory diseases.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
RECOMMENDED TRAINING
1/5
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