Associate Director, Commercial Product Quality US Regional Lead, External Supply Quality

**General Description:**

The Associate Director, Commercial Product Quality US Regional Lead in External Supply Quality organization is responsible for ensuring that externally manufactured commercial products are manufactured, packed, labelled, stored and transported in a controlled way at Contract Manufacturing Organizations in accordance with the regulatory expectations and applicable GMP/GDP quality standards. The role has global responsibility and accountability for commercial product quality for global supply. The scope will also include product life cycle management projects.

The job holder will support and ensure the compliance to applicable international regulations and BeOne quality standards and procedures at CMOs.

The scope of the role will include but not limited to the following,

+ Small molecule and large molecule commercial products in the US
+ For DS, DP and FP
+ Managing quality issues and changes at CMOs
+ Post approval ch...