Biologics QA Specialist – GMP, NPI & Compliance

Amgen SA; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Amgen is seeking a Specialist Quality Assurance I to provide oversight and leadership for quality systems execution and operations support across non-direct manufacturing areas in Biologics and Synthetic Manufacturing.

You will support GMP documentation, deviation investigations, change controls, and CAPA, and interact with regulatory inspectors while coaching QA professionals and driving continuous improvement.

Qualifications

• Doctorate or Master’s with GMP experience in pharma.
• Bachelor’s with 4+ years in GMP environment or Diploma with 8+ years.
• 8 years+ experience in pharma/biologics with increasing responsibility.
• Experience with regulatory audits and inspections.
• Strong written and verbal communication and project management skills.
• Direct experience with bulk manufacturing of biopharmaceuticals/API preferred.

Responsibilities

• Provide quality oversight to plant operations ensuring GMP compliance.
• Review routine GMP documentation (SOPs, logbooks, work orders, validation docs).
• Co-lead deployment of Amgen quality systems (management review, validation, deviation, change control, CAPA).
• Review and approve deviations, investigations, testing, change controls; lead root cause analyses.
• Lead QA oversight in commissioning/qualification projects or NPI.
• Coach QA professionals on resolving quality issues; participate in regulatory inspections.
• Lead or support quality system initiatives and continuous improvement projects.

Skills

Quality oversight

GMP compliance

Regulatory inspections

Documentation review

Education

Doctorate Degree

Master’s degree

Bachelor’s degree

Diploma

Tools

SOP management systems

Job description

Amgen is seeking a Specialist Quality Assurance I to provide oversight and leadership for quality systems execution and operations support across non-direct manufacturing areas in Biologics and Synthetic Manufacturing.

You will support GMP documentation, deviation investigations, change controls, and CAPA, and interact with regulatory inspectors while coaching QA professionals and driving continuous improvement.