Quality Director
Annual Package：CNY700,000 – CNY900,000 per annumWorkplace：Suzhou Consultant：Len Zhou
Responsibilities：
• Build and maintain robust quality program that will effectively support clinical and commercial manufacturing operations;
• Conduct ongoing evaluations of quality programs, systems and initiatives to assure that product quality standards and regulatory compliance are achieved;
• Interpret Regulatory Authority regulations, guidelines and policies. Utilize internal audits and quality compliance assessments programs to improve compliance processes and procedures;
• Direct the review and approval of the Quality Manual, Quality Policies, Protocols, SOPS, Batch Records, Test Methods, Raw Material Specifications, and Annual Product Reviews and CAPAs;
• Ensure that manufacturing processes, equipment, facilities and systems are validated and that a robust Change Control system and procedures are developed and maintained to meet worldwide regulatory standards;
• Develop and execute Site QA operating and capital budgets and manage department efforts to control costs within approved levels;
• Provide leadership and managerial oversight to the quality department. Develop staff and work closely with them to ensure that a consistent approach is taken in evaluation and resolution of quality issues.
Requirements：
• BS degree in a scientific discipline (i.e. Chemistry, Microbiology, Chemical Engineering);
• A minimum of 10 years experience in the pharmaceutical industry;
• Good interpersonal and problem solving skills;
• Must have a quality background from the biotechnology/pharmaceutical industry with GMP experience and a successful track record in quality within FDA and/or EMA regulated environment;
• Demonstrated leadership in cross-functional and culturally diverse team settings.
Len ZhouDirector—Manufacturing
I have 8 years’ working experience in human resources of manufacturing enterprises, especially in the recruitment field, I am familiar with the recruitment system, recruitment and evaluation means application. I joined the executive search industry for the love of recruitment and then I engaged in continuous improvement, production and operation, quality management and all levels of positions. At present, I focus on quality management, continuous improvement and EHS recruitment.
