1.Document, Data and Change Controls

Create, timely review and revise/maintain LOC procedures related to PQC management in accordance with local GxP, QMS and J&J requirements.

Execute minimum requirements regarding lifecycle management of GxP related documents and records (creation, approval, distribution, revision, retrieval, retention and disposition) to ensure regulatory compliance and business continuity.

Ensure appropriate internal and external change control systems are followed.

2.Qualification and Training

Support the preparation, revision, training and implementation of global CQ/local LOC procedures in accordance with local GxP, QMS and J&J requirements and support the provision of appropriate GxP/product training for all job functions.

3.Inspection and audit management

1.BA/BS, advanced degree or equivalent preferred;

2.High level of integrity and compliance concept with good ethical core values;

3.Knowledge of pharmaceutical or other regulated industry is preferred, ideally with a mix of Quality and Compliance, Pharmacovigilance, Regulatory Affairs;

4.Demonstrate strong organizational, interpersonal and communication skills;

5.Highly self-motivated, strong agility and resilience;

6.Independent and objective thinker;

7.Manages conflicts in and open and constructive manner;

8.Fluent in both Chinese and English (reading, writing, verbal);

9.Master of Microsoft Office software (Word, Excel, PPT).