Remote External Supply QA Manager

Amgen SA; Dún Laoghaire; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Remote work

Job summary

Amgen seeks a Quality leader to provide oversight of drug product manufacturing at CMOs, ensuring GMP compliance and regulatory readiness. Lead deviations, change controls, CAPAs, batch disposition, and QA reviews, while coordinating with internal partners and external CMOs.

The role requires a science degree with 4+ years in biotech/pharma quality or manufacturing, strong cGMP experience, and the ability to manage multiple projects and cross-functional teams. Travel up to 20% may be required.

Qualifications

• Requires Doctorate/Master/Bachelor with related experience or equivalent.
• Strong knowledge of cGMP and quality systems.
• Experience leading cross-functional quality and manufacturing teams.

Responsibilities

• Be an integral quality member of cross-functional contract manufacturing teams.
• Lead representation and management of quality issues with internal and external partners.
• Serve as QA contact for deviations, change controls, CAPAs, and batch disposition.
• Manage CMOs to contractual Quality Agreement,Amgen specifications, regulatory requirements.
• Review production batch records and approve master batch records and cGMP docs.
• Provide quality oversight of manufacturing, testing, and release of Amgen products at CMOs.
• QA review of documentation for batch release to ensure GMP compliance.
• Draft and approve quality agreements and inspectors' readiness.
• Prepare site for regulatory inspections and represent Amgen at inspections.
• Contribute to successful regulatory inspections and audit readiness.
• Review/Approve Master Batch Records and prepare inspection playbooks.
• Identify and mitigate risk at CMOs or testing labs; escalate when needed.
• Perform Person in Plant activities as required; provide QA support for NPI, tech transfer, PPQ, filings.
• Monitor site performance via quality metrics and communicate with Amgen and CMOs.
• Identify prioritization opportunities and manage cross-functional relationships.
• Lead submissions activities at CMOs for international launches.

Skills

Quality management

Manufacturing

cGMP

Project management

Cross-functional leadership

Stakeholder management

Regulatory inspections

Education

Doctorate

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

GxP systems

Quality systems (Document control)

Job description

Amgen seeks a Quality leader to provide oversight of drug product manufacturing at CMOs, ensuring GMP compliance and regulatory readiness. Lead deviations, change controls, CAPAs, batch disposition, and QA reviews, while coordinating with internal partners and external CMOs.

The role requires a science degree with 4+ years in biotech/pharma quality or manufacturing, strong cGMP experience, and the ability to manage multiple projects and cross-functional teams. Travel up to 20% may be required.