Assoc. Dir, External Quality
Core
Strategic oversight of global API suppliers to ensure compliance with cGMP, regulations, and company standards, safeguarding product integrity and patient safety.
Role type
Senior IC supplier quality assurance director
Builds
Robust supplier quality systems and audit-ready processes for API manufacturing, packaging, testing, and distribution
Domain
Pharmaceutical manufacturing (API) / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (supplier audits and quality oversight)
Required skills
GMP compliance, risk-based supplier assessment, root-cause analysis, regulatory framework knowledge, change control management, deviation investigation, quality agreement negotiation, cross-functional collaboration, English fluency, Chinese fluency
Preferred skills
Sterile manufacturing experience, biologics/vaccines knowledge, technology transfer support, regulatory inspection readiness, electronic QMS proficiency
Technologies
TrackWise, LIMS, Excel
Responsibilities
Lead on-site/remote supplier audits and issue evidence-based reports; manage supplier change controls and regulatory impact assessments; investigate deviations, OOS/OOT, and complaints; coach supplier and internal teams; monitor supplier performance via KPIs; represent company during regulatory interactions
Seniority
Senior, hands-on IC with strategic influence