Senior Quality Assurance Manager - BioScience
Core
Lead Quality Assurance team to enforce cGMP standards, manage quality systems, and ensure compliance for Active Pharmaceutical Ingredients (APIs) and medical device components.
Role type
Senior Quality Assurance Manager (Pharmaceutical/Medical Device Manufacturing)
Builds
FDA-registered facility operations producing APIs and medical device components
Domain
Pharmaceutical and medical device manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, Quality Management System (QMS) oversight, regulatory audit management, root cause analysis, risk management (FMEA), data-driven decision-making, team leadership, change control coordination
Preferred skills
Six Sigma Black Belt, Certified Quality Manager (CQM), Certified Quality Auditor (CQA), bilingual Mandarin/English
Technologies
TrackWise Digital, TrackWise QMS modules
Responsibilities
Lead and manage QA team for cGMP compliance; Provide strategic direction on quality matters; Drive continuous improvement in QA operations; Maintain inspection readiness for FDA/EU; Oversee QMS records and investigations (OOS, CAPA, deviations); Collaborate on process validation and regulatory submissions
Seniority
Senior, hands-on IC with management responsibilities
