北京招聘

US Listed Group Company:

General:

The Director of Quality Assurance will oversee staff and operations for all Quality Assurance functions including QA Operations, divisional budget and manage a staff of 12 Direct Reports. The Director is tasked with building a strong, long-term team where the staff maintains the highest standards of Manufacturing Process Quality Assurance. This visionary leader, through innovation of operational efficiencies, quality and compliance, will help Company increase their Global fingerprint and improve quality standards within the organization at large. The Director is responsible for managing and coordinating all quality functions on the manufacturing. The QA Director, in cooperation with the VP Operation, will implement a cultural shift toward higher compliance standards and organizational efficiencies. This individual maintains responsibility for all aspects connected with plant GMP compliance including the development, analysis and reporting of support data and communications between SFDA and quality assurance. S/he is responsible for addressing all quality issues in a timely fashion and communicating that information to the support groups as well as the oncoming shift management team.

Responsibilities:

Review and approve all test protocols and data with particular emphasis on those that affect equipment and facility design and/or operation.

Review and approve all manufacturing and control procedures and specifications, as well as provide the required function guidance for their development

• Provide the required function guidance for the development of procedures and specifications
• While working with shift supervisors, manage the quality activities
• Prepare and maintain the budget for all functions in the area
• Hold direct responsibility for managing and coordinating all quality functions on the manufacturing floor.
  Address all quality issues in a timely fashion and communicate that information to the support groups as well as the oncoming shift management team
• Ensure and enforce compliance with GLP, GMPs, corporate and plant policies, processes and procedures

Leadership Competencies:
Change Agent -This individual will work directly with the Plant Quality Assurance Director to help elevate the cultural qualityand compliance standards of the facilities with respect to personnel and processes.
Team Building -This individual will model and "raise the bar" of Leadership through Team building and development.
Succession Planning -This individual will identify, cultivate and advance key leaders within the group for career succession.
Manufacturing Quality Process Improvement -This individual will integrate "best in class" thinking throughout the complete manufacturing process "above and beyond" cGMP standards.

Pro-Activity / Urgency -This individual will apply "critical thinking and analytical assessment" to his/ her management style to respond in a 'constructive rather than reactive' way to troubleshooting / problem solving.

Qualifications:

Requires a bachelor's degree in science or related field

Minimum of 7-10 years of biopharmaceutical and/or quality assurance experience

Previous supervisory/management experience is required

Current knowledge of cGMP's and regulatory changes in the industry are also required

Manufacturing floor experience

Must have excellent verbal and written communication skills

Superior technical writing, problem solving and presentation skills are required

If you would like to apply for this role or find out more, please contact hr@tojob.cn

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