Regional Manager, Quality Assurance
2 weeks ago
**Primary Responsibilities**:
**Manage quality operations in the Asia Region, ensuring compliance to the Company’s standards and local regulatory requirements for their products.**:
- 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 Company’s 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 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)
- Proven experience of stakeholder management (e.g. distributors, regulatory authorities)
- Audit and inspection experience (e.g. internal, regulatory authority, CMO, supplier)
**Next Steps**:
Principal Consultant: Cheong Yee Yin
Registration Number: R22108633
EA License Number: 17C8502
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