Brighton Tan

ROCHE PHARMA

Global Quality Manger  Aug 2021- Now 

• Fulfill GMP document for  new launch, variation, renewal HA submission  
• Govern compliance for new distribution model ( eg: rare disease and gene therapy) 
• Catalyst for new product launch at various markets  
• Set up legal manufacturer distribution operation for medical devices 
• Ensure GCP for IMP & clinical trial distributions 
• Drive GxP synergies between GMP/GDP & GCP/PVA compliance
• Optimize resources within global quality community   

Senior Manager, APAC Commercial Quality  Oct 2020- Now

• Provide quality leadership and compliance oversight for APAC region (11 affiliates + 7 direct markets) 
• Quality focal point for APAC senior management & global quality network 
• Collaborate with Commercial & Business, Supply Chain, Regulatory and Patient Support for value co-creation to enhance distribution capabilities, customer experience and healthcare partnership   
• Ensure effective implementation of Global Quality Systems across network.
• Champion QBR, new affiliates set-up, compliance risk assessment 
• Enable affiliates the right license to operate. Ensure market and patient access, new product launches, and prevention of supply disruptions (eg: stock outs & backlot) 
• Support quality management for product life cycle  from product registration, market  access,  launches, establishment & commercial, technical transfer to divestment, medical affairs and Pharmacovigilance  
• Support global issue management for stock out escalation, recall, health authority notification & critical product complaints 
• Act as catalyst to promote quality value preposition. Act as ambassador to influence & shape health care ecosystem 
• Drive global fit-for-purpose solutions eg: digital and automated system via Minimum Viable Product (MVP) cycle in Agile approach     

Diploma in Advanced Management & Leadership 2020 (Singapore Management University)  

Advance Diploma in Training and Assessment 2016 (Institute of Adult Learning)  

Master in Philosophy 2009 (National Taiwan University)

Degree in Mechanical Engineering, 2004 (National University of Singapore)