M&S Quality Services, Third Party Audits Manager - KL Hub
Core
Drive quality assurance across Third Party Manufacturers and Contract Manufacturing Organizations by planning and executing GxP audits, assessing regulatory compliance, and identifying gaps with actionable CAPAs.
Role type
Senior IC Quality Audits Manager (Third Party/CMO)
Builds
cGMP-aligned supplier audit programs and inspection readiness for global quality teams
Domain
Pharmaceutical/Biotech manufacturing and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Quality Audits & Compliance)
Required skills
GxP/cGMP audit execution, Root Cause Analysis (RCA), CAPA management, regulatory framework interpretation (FDA/EMA), supplier qualification, team coaching, process improvement
Preferred skills
Mandarin or Japanese proficiency, experience with highly sophisticated quality topics
Technologies
Quality management systems, regulatory intelligence tools
Responsibilities
Plan and perform on-site and remote GxP audits of third-party vendors, lead the Quality Compliance team to ensure cGMP compliance, support root cause analysis investigations, coach auditors and assess training needs, monitor FDA/EMA regulatory changes, propose innovative process improvements, manage supplier audit programs and follow-up on regulatory audits
Seniority
Senior, hands-on IC with team leadership