Global Quality Manager

Major Responsibilities：

• Participates as a key member of teams or committees throughout the global PTQ organization for strategy and policy, external interactions and influencing activities as they relate to Quality and GMP/GDP Compliance.
• Support the overall efforts for strong health authority relationships in the areas of Quality and Compliance through effective communications, interactions and participation in meetings, conferences and committees with focus on respective region or area of expertise.
• Develop and maintain relationships with industry and regulatory bodies in specific regulatory regions of the world assigned, with specialized expertise in requirements and trends in that region,  while being aware of global effects and strategies as they affect Quality and Compliance
• Establish and maintain strong, effective positions within key industry/trade organizations including technical task teams, groups or through written media, e.g. technical articles to influence industry positions on key strategic Quality topics 
• Provide up to date regulatory and compliance information and trends, specializing in specific regulatory authorities and regions, providing timely information to the PTQ organization
• Contribute to formal written communications within the PTQ organization updating on the regulatory environment
• Contribute to PTQ regulatory , quality and CMC strategies based upon latest regulatory and technical trends derived from industry and regulator interactions and communications
• Coordinates with SMEs throughout the PTQ organization to understand their needs, work with outside bodies to influence on these and to engage SMEs in regulatory and industry interactions , meeting and  committees including technical  journals and other media to influence and collaborate on technical and regulatory issues

Requirement：

• Bachelors or advanced degree in technical area; certification or training in quality and technical areas is desirable e.g. ASQ. ,continuing education or in house training
• Fifteen or more years’ related professional experience in regulatory, quality or process development
• Proven ability to be part of a team responsible for  the execution of successful innovative GMP and CMC regulatory strategies in the areas of Quality and Compliance
• Proven ability to communicate and interact with global health authorities
• Expert in the area of Quality and Compliance including primarily GMP/GDP and also CMC issues
• Experience with manufacturing, analytical, compliance, and regulatory issues including knowledge of quality systems, quality risk management and their relationship to manufacturing
• Prior industrial or regulatory agency experience including leadership roles in applying quality systems to the manufacture of pharmaceuticals through various lifecycle stages
• Interaction with industry and professional organizations in manufacturing quality areas to include participation or leading workgroups and giving presentations.
• Ability to travel domestically and internationally 30%