Quality Integration Leader

Our client is a publicly traded, Global Top 10 pharmaceutical company which offers a wide range of healthcare products and is a global leader in innovative pharmaceuticals, generics, vaccines and consumer health products. In 2008, Global Sales exceeded US$30 billion with over 100,000 associates employed at more than 140 offices globally.

This position is responsible for all quality aspects related to the integration of The plant into the Vaccines network; this includes the development of the Quality integration strategy, the direction regarding detailed gap assessments and priorities, development of risk mitigation strategies, capability assessments of the local organization, training and the implementation of the Vaccines Quality System in alignment with our client company's Quality Operations strategy. This position will report to the Global Head of Quality.

Summary of Key Responsibilities:

• Development of the detailed Quality Integration strategy for the plant
• Coordination of implementation of the Quality Integration strategy with other integration work streams, mainly Technical Operations, IT, and New Product Development
• Coordination of detailed gap assessments and the development of remediation plans ensuring proper priorities
• Monitoring and reporting on progress of remediation plans. Escalation of issues to the steering committee
• Development of risk monitoring and risk escalation tools; oversight over risk mitigation activities. Establishment of site quality risk assessment methodology and routine updates
• Capability assessment of the local Quality organization
• Facilitation of training and development of the local staff
• Relationship development and management with SFDA: development of routine interactions and involvement in escalation issues with the agency
• Development of timeline, facilitation and reporting of implementation of current local GMP's (major update of SFDA GMP's to be effective in 2010)
• Development of timeline, facilitation and reporting of implementation for qualification by WHO
• Development of timeline, facilitation and reporting of implementation of our client company QM systems at the plant
• Participation in development of IT system strategy and lead for development of strategy of roll out of IT systems supporting the Quality systems .

• Has previous Aseptic Filling Quality management background
• Minimum 15 years working experience in Quality and related Manufacturing roles within global Pharmaceutical companies
• Strong knowledge of global GMP, GCP standards
• An independent and hands-on person with a good balance between managerial and technical skills
• If overseas Chinese, needs to have the passion for a local culture and willingness to adapt to life in China
• International education with a pharmaceutical background/qualification preferred
• Fluency in written and spoken English and Mandarin Chinese.

How to apply for the Quality Integration Leader role:

1. Click the button below to raise an email form
2. Attach your CV file to the email
3. Add any covering letter / personal notes to the body of the email
4. Send your completed job application through to us for processing.

Alternatively, for a confidential discussion concerning the Quality Integration Leader opportunity you can telephone Vaché Petrossian on +86 (21) 6288 3632. Please be sure to quote 10224 in all correspondence relating to this role.