Regional Quality Assurance Manager

Overview

Manage quality operations in the Asia Region, ensuring compliance to the Companys standards and local regulatory requirements for their products.

Main Responsibilities

• Asia QA Team representative/QA Lead, Quality Management Representative in responsible countries
• Leading operational quality assurance activities in Asia in the importation, secondary assembly/repackaging, storage, distribution of the Companys products
• Develop, executive and maintain QMS
• Oversight of CMOs/Suppliers
• Plan, perform and ensure successful closures of internal and external audits
• Provide post market support and resolve quality issues promptly
• Drive the continuous supply of quality compliance products
• Provide quality improvement inputs and support to new product introduction/product launches

Requirements

• At least 5-7 years quality assurance experience in pharmaceutical and/or medical devices company
• Experience in both manufacturing environment and commercial quality
• Experience in quality operation activities (i.e., importation, repackaging, release, storage, and distribution) of pharmaceutical and medical devices products (including sterile, liquid/solid products, cold chain management)
• Fluent in knowledge and application of GxP standards (e.g. Good Manufacturing Practice, Good Distribution Practice), ICH, ISO9001, ISO13485, PIC/s
• Proven experience of stakeholder management (e.g. distributors, regulatory authorities)
• Audit and inspection experience (e.g. internal, regulatory authority, CMO, supplier)