Senior Specialist External Quality
Core
Managing supplier quality assurance, audits, and compliance for pharmaceutical distribution across the Asia-Pacific region.
Role type
Senior Specialist External Quality (Pharmaceutical Distribution)
Builds
Quality systems and compliance frameworks for external suppliers and 3PL partners.
Domain
Pharmaceutical industry, Supply Chain/Distribution, Quality Management (GDP/GSP)
Deliverable
client delivery
Required skills
Supplier quality management, QA audits, risk assessment, change control, deviation investigations, GDP/GSP regulations compliance, 3PL oversight, health authority inspection preparation, quality training delivery, cross-functional collaboration, issue resolution, coaching and mentoring.
Preferred skills
Licensed pharmacist status, experience interacting with health authorities, multi-site/multi-functional experience.
Technologies
Drug traceability systems, QMS procedures.
Responsibilities
Conduct QA audits and supplier risk assessments; manage distribution-related quality complaints and deviation investigations; oversee 3PL drug inspection and traceability setup; prepare for and manage Health Authority inspections; provide quality advice to Distribution Managers; perform GDP/GSP regulations assessments; lead quality management reviews and issue resolutions; draft and approve QMS procedures for distribution.
Seniority
Senior, hands-on IC
