上海招聘

We are helping one of our corporate clients - a globally recognized management consulting firm specializing in services to organizations in the pharmaceutical, biotechnology/biologics, medical device/diagnostics and other FDA regulated industries to identify strong and talented candidates for the below position:


Job Description:

Candidates must possess an understanding of cGMP and Chinese regulations, and the ability to apply risk management tools and must have a minimum of 10 years' experience in R&D, Quality Assurance, Regulatory Affairs or compliance in the pharmaceutical industry.


Duties & Responsibilities:

? Coordination of regional audits and quality oversight of the clients suppliers and finished dosage forms manufacturers in the China;

? New product registrations to SFDA and product release to the Chinese market and ensuing pharmacovigilance activities;

? Partnering with the clients to execute their Global Quality Policies and Standards in the region, and other quality support activities;

? Provide support to registration dossiers review and product release review to ensure suitability for distribution in China;

? Provide supports to the clients safety group for reporting of adverse events and complaints;

? Lead and manage staff to achieve goals and objectives to ensure compliance with all applicable regulations;

? Act as a key component of the project team to execute client projects regarding QUALITY ASSURANCE and for administration and coordination of the daily QUALITY System;

? Responsible for managing all communication with client key stakeholders. Acting as a member of a project team;

? Analyze, evaluate, and present information concerning QUALITY ASSURANCE related to current and possible future products with other members of the project team;

? Evaluate contents of reports regarding product ASSURANCE issues and confers with management on specific project and other issues;

? Review technical problems and procedures of client and recommends solutions to problems or changes in procedures regarding QUALITY issues;

? Assess client's project requirements. Establishes QUALITY requirements of external suppliers; conducting or overseeing supplier qualification audits;

? Assist with the design and execution and implementation of an effective Corrective Action program to prevent reoccurrence or occurrence of QUALITY problems;

? Manage subordinate supervisors and managers who supervise employees in Regulatory ASSURANCE and QUALITY ASSURANCE. Responsible for the overall direction, coordination, and evaluation of these units.


Requirement on Experience:

? At least 15 years of pharmaceutical manufacturing, quality and FDA regulatory experience. Relevant knowledge of GMP, and regulatory requirements;

? Demonstrated ability to construct and implement GMP documents, quality and/or FDA compliance investigatory writing experience;

? Leadership/Managerial and effective communications skills;

? Able to under pressure to meet deadlines;

? A minimum of a BS Degree in engineering or science.

Since its establishment in 1996, registering the first US state office in China, The Center of American States (CAS) is now home to Maryland Center, D.C. Center China, Tennessee Center China and the Council of Great Lakes Governors China operations, including Michigan China Center, Minnesota Center, and Wisconsin Center China.
Strategically located in Shanghai, China’s financial heart, the CAS is well positioned to advance the interests of our states and develop commercial and cultural links between China and states we represent.

CAS Specializes in a wide variety of services including:
Export Promotion
Investment Attraction
Education Initiatives and Programs
Destination Marketing and Tourism
Sister state/city relations
Trade Mission Support
Strategic Government Relations
PR and Media
Special Event Management
CSR