Amgen Singapore Manufacturing
biotechnology
AssociateDirectorQualityAssurance
“Associate Director Quality Assurance at Amgen Singapore Manufacturing. Skills: Quality Assurance, Quality Management Systems, GMP Oversight, deviations, CAPAs, Change Controls, Quality Risk Management, Document Management System. Providing oversight and leadership for Quality on-the-floor and functional area support. support all direct manufacturing”
What You'll Achieve.
ensure key performance indicators meet targeted metrics; Ensuring timely closure of Quality records; Ensuring timely review and approval of documentation
Industry & Context.
root cause investigations; root cause analysis tools
medical requirements of this job scope
What They're Looking For.
Must Have
Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and/or 8 years of directly related experience, Good understanding of IS system compliance with hands on experience of Computer System Validation or Compliance, 10 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems.
Nice to Have
Direct experience with bulk manufacturing of biopharmaceuticals preferred.
What You'll Do.
Providing oversight and leadership for Quality on-the-floor and functional area support
support all direct manufacturing
leading and guiding a team of FTEs
trainees and a number of CW Staff
quality oversight of day-to-day activities
CAPAs and Change Controls
managing Subject Matter Experts
Ensuring Quality Assurance support for all ASM1 manufacturing activities
on-the-floor quality oversight
quality records approval
Support routine GMP Oversight activities
ensure key performance indicators meet targeted metrics
Ensure required Quality resources are available to support commercial operations
Inspection Readiness and Support
Participate in root cause investigations for complex and significant exceptions or issues
Support site/network driven QA continuous improvement initiatives/activities
Escalate significant quality issues to Quality Management in a timely manner
Act as delegate to Quality Assurance Director when required
Support Drug Substance Alignment Meetings for Functional areas
Providing guidance to the team
Ensuring alignment across the Quality Teams
Supporting critical deviation resolution
Ensuring timely closure of Quality records
Ensuring timely review and approval of documentation
Supporting the team in critical meetings
Attend project and strategy meetings
Meeting with the Functional Area/ Leadership monthly
Plant QA/Manufacturing Support QA Huddle attendance
SQDIP attendance ASM1
Attend the Weekly Operational Meetings for ASM1
Team one to one meetings
XLT Meeting attendance
Schedules tasks and ensure a level workload for the team
How You'll Work.
Team & Collaboration
Ensuring alignment across the Quality Teams; Supporting the team in critical meetings; Meeting with the Functional Area/ Leadership monthly; Team one to one meetings; Weekly Team Meeting; XLT Meeting attendance
Communication Scope
written and verbal communication skills; technical writing; presentations; communicate and collaborate effectively with technical and senior management staff
Process & Methodology
project management, project management
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