The world's most comprehensive and broadly based healthcare Company competing in consumer, pharmaceutical and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

Job Responsibilities

·         This position is responsible for establishing and maintaining a network of effective business partner relationships across Asia, including but not limited to the Clinical Development Operations (CDO), Global Medical Services (GMS), Drug Safety Sciences (DSSc), Information Technology Services (ITS), Global Pharma Sourcing (GPS), and Medical Affairs (MA) business units to effectively collaborate on proactive quality measures and quality improvement activities when necessary.

·         Provides local strategic leadership to the GR&D QA Asia regional team to assure the success of the AP strategy, provide standardization and consistency in decision-making, and a comprehensive, innovative, risk based compliance program across the Pharmaceuticals Group.  Coordinates resources with other Global R&D Quality leads to ensure the ongoing effectiveness of the compliance program.  Partner with the Asia R&D Leadership team.

·         Responsible for ensuring routine assessment of Asia regional compliance and risk through evaluation of metrics and management reports and advises on potential compliance risk areas and recommends and implements appropriate action plans.  In addition, must also ensure that services provided by the GxP teams are timely, sufficient, accurate, effective and appropriate.  Participates in appropriate Quality investigations.

·         This position plays a strong role in influencing the external regulatory and industry environments and is also responsible with other GxP QA functions to lead inspection readiness support at all times.  

Qualifications Required

·         A Bachelor of Science (BSc) degree in a life science, natural science or computer science is required.  An advanced degree (M.D, Ph.D, MSc or Pharm D) would be desirable.

·         Requires at least 8 years of experience in an applicable compliance field and/or equivalent time and experience in a related R & D area (GXP regulated discipline) including five plus years of experience and demonstrated leadership in a quality function.

·         Individual must be strategically oriented in compliance with a proven track record of sustaining compliance in complex organizations. 

·         Excellent organization, communication (written and verbal), investigation, and negotiation skills and be diplomatic.  A proven track record of leading and developing people.

·         Experience with influencing organizational leadership and Health Authorities to accomplish specific business and financial objectives.