APAC Compliance, Commercial & Distribution QA Associate Director
Core
Provide Quality Systems leadership, tactical and strategic direction, and technical support to commercial affiliates in the APAC region to ensure compliant, authentic, safe and efficacious products are supplied.
Role type
Associate Director, Quality Assurance (Commercial & Distribution)
Builds
Regional supply chain and distribution activities, including GDP training, internal audit programs, document control, quality manuals, returns management, complaints and discrepancy investigations, and CAPA processes.
Domain
Healthcare / Pharmaceutical / Quality Assurance / Supply Chain
Required skills
Quality Systems leadership, GDP compliance, audit management, supply chain validation, counterfeit prevention, CAPA management, project management, root cause analysis, regulatory knowledge, change management, risk management
Preferred skills
Commercial and distribution quality experience, Lean/Six Sigma, GxP audit support, temperature monitoring, serialization, material listing approvals
Technologies
Quality management systems, document management systems, serialization tools
Responsibilities
Provide Quality Systems leadership to commercial affiliates; Maintain quality systems supporting regional supply chain and distribution activities; Select and approve Logistics/Transport Service Providers and Third-Party Warehouses; Collaborate with Supply Chain, Distribution, and Global Product Protection teams on projects including counterfeit prevention and supply chain validation; Develop and manage the APAC Commercial Affiliate Quality Plan; Support local market outsourcing activities and product launches through management of the First Lot Quality Review program; Drive Management Review processes for commercial affiliates; Oversee Quality and Compliance activities across the APAC region; Lead regional GMP training management; Support GxP audits for APAC suppliers and affiliates.
Seniority
Associate Director, strategic leadership with hands-on execution
