Head of Quality of Greater China

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For more than 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. 

bioMérieux is present in 45 countries and employs nearly 14,000 people. In Asia Pacific, we have more than 1100 employees with presence in 10 countries.

Come and join a French family-owned global company with a long-term vision, and a human-centered culture. 

What will your responsibilities be within bioMérieux?

• Serve as the Quality Management Representative for Great China organization;
• Overall supervision of quality management system for all entities, also including other collaborative projects with strategic partners;
• Ensure the deployment of the Quality Policy and Objectives and maintain the effectiveness of the Quality Management System;
• Ensure the conformity of the Quality System towards regulatory requirements, including ISO9001， ISO 13485, Medical Device and IVD Regulation in China
• Implement Quality Compliance training programs that provide necessary organizational knowledge to achieve company and regulatory objectives;
• Ensure that written procedures are maintained to define the specifications and procedural requirements affecting product quality, and that effective change controls are maintained to assure that any changes are thoroughly reviewed and shown to be appropriate, including review for their potential to affect validations or regulatory submissions;
• Monitor the implementation of Corrective and Preventive Action programs including necessary procedures, records, and trend reports.  These programs lead to process and product improvements;
• Maintain and improve reports of quality data to assist the continuous improvement of quality and analyze them to assess the effectiveness of the company quality system.  Leads major quality transformation programs and acts as a key advisor to senior leadership on quality risk, performance, and regulatory trends;
• Report on the functioning of the Quality System to top management and leadership team as responsible for conformity with the requirements of the Quality Management System; Ensure that  organization and quality control procedures to perform  the testing of raw materials, components, semi-finished and finished products, are relevant, validated and in compliance with the customers’  expectations and regulatory requirements; Responsible for the batch release management; Monitor validation master plan.
• As the primary contact of the local organization with regulatory authority, certification body and Global organization of BioMérieux SA;
• Manage the team of Quality department; Lead and facilitate team to accomplish the deliverables, milestones, and objectives meeting the plans ensuring that any changes to the plans are communicated and agreed by the teams and project sponsors.
• Communicate progress of the Quality objectives to all levels of the organization.
• Oversee post market surveillance activities including customer complaints handling resolution, field action, adverse event reporting.
• Keep strong relationships with internal and external stakeholders to ensure alignment across local and global functions.  

Who are you?

Studies-Experience:
-    Bachelor’s Degree with >10 years of industry experience or equivalent experience in related industry.
-    >10 years managerial experience 
Skills and Qualifications:
-    Strong leadership and communication skills.
-    Experience in participation in quality system and regulatory audits (i.e. ISO 9001, ISO 13485, NMPA, MDSAP, etc.).
-    Knowledgeable in relevant Domestic and International Regulations and Industry Standards
Work locations, both Shanghai and Suzhou

bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.