Job Purpose 岗位目的
The job exists within China Local Operating Company.
The job holder is expected to proactively support quality compliance with ChP/ Quality regulatory Intelligence(QRI) for China business and protecting product licenses to operate.
The effective collaboration with internal and external stakeholders to gain compliance on ChP monographs including Active substance/Excipient/Primary Packing(AEP) and General Chapters update and revision.
Work closely with LOC RA and Global quality regulatory compliance team(China compliance team & QRI) to secure in timely commenting to proposed ChP updates and compliance after ChP effective.
Leading new NMPA related key regulation and requirements explication of potential impact & gap to GSK internal sites and/or CMO sites through QRI procedure.
Key Responsibilities (10 bullet points maximum)主要职责（最多10项）
Describe the key deliverables, specific duties, any specialist duties and the ongoing responsibilities of the role.
Management of ChP and QRI
Lead ChP and QRI coordination, including identifying, monitoring, delivering, tracking and communicates relevant new ChP monographs, AEP, general chapters and key NMPA regulations in an expeditious manner to relevant stakeholders.
Ensure robust ChP / QRI process and fast escalation of potential risks.
Take lead for ChP and QRI translation management and deliver correct key informations.
Coordinate with internal stakeholder (global QRI, China Compliance team, Global SME, RA etc.) to identify any direct impact to product quality and regulatory compliance.
Assess and proactively identify continuous improvement opportunity for the adoption of the updated ChP and QRI requirements.
Coordination with internal speakers for external meetings related with ChP and QRI topics i.e CPEC, ISPE, CPAPE etc.
Support business operation compliance/ inspection readiness on ChP and QRI across products and manufacturing sites.
Strengthening relationships with GSK network of partners. Build trust with external stakeholder (CPC regulators and RDPAC ChP group).
Lead purchase activity for ChP materials and advocacy membership/meeting fees.
Supporting advocacy which topics related with ChP. Influencing/Advocating on key changes affecting the business.