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Quality Compliance Manager

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Want to raise standards for quality? As Quality Compliance Manager you’ll have the freedom to find ways to take a world-class manufacturing operation to the next level. 
 
 Quality Compliance Manager 
 Suzhou, Jiangsu 

•To develop/maintain the site quality management system and ensure its compliance to RB global and regulatory requirement.
•To manage the supplier, EMB and EMO in a good quality level, and in compliance with global requirement.
•Key player in GMP compliance and accountable for TW system management, consumer& customer complaint, internal and external audit.
Accountabilities:
•To input strategy direction (design, development and implementation of standard&policies) to Taicang quality and in alignment with health sites within RB.
•To integrate global QMS, regulatory requirements into local QMS by working with cross functional team and ensure local activities are fully in compliance with it.
•Alert local team to check the compliance level and update local QMS with CAPA when necessary for any global QMS, regulations change or update.
•Ensure local QMS documents are reviewed and update as appropriate.
•To ensure that quality related documents/records are maintained in line with appropriate regulations and internal policies.
•To conduct training needs analysis, develop site quality training plan, and deliver the trainings per timeline.
•To continuously drive the quality culture and improve the quality awareness in site with routine activities such as quality training, quality day, questionnaire, post etc.
•To manage the market surveillance, corporate audit, cross audit, external audit, develop internal audit schedule, conduct mock recall with domestic/oversea countries.
•To manage customer & consumer complaints, lead root cause analysis and build robust CAPA.
•To continuously improve RB supplier, EMB & EMO quality management system.
•Lead the quality issue/complaint investigation and CAPA related with suppliers.

 

Requirments:
•Bachelor’s degree or above in Chemistry Engineering, Applied Chemistry, Food or Pharma related.
•Familiar with relevant laws and regulations of disinfectants, cosmetics and medical device, ISO 22716, ISO13285, GB/T 38503 etc.
•At least 5 years’ experience in management field of quality.
•Entrepreneurial decision-making skills and communication skills.
•Strong target orientation and highly motivated.
•People management- Proven experience in leading and developing teams, able to effectively influence people of all levels to drive change and improvement.

Equality


Job Segment: Medical, Medical Device, Healthcare

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