Senior Director, China Commercial Quality

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Position Summary

Quality head of JJMS & HCS responsible for organizing the formulation of quality management system to meet China regulatory requirements, ISO 13485 standard, China GMP for Medical Device and J&J Enterprise requirements where applicable, guide and oversees the implementation of the system and carrying out inspection, correction and continuous improvement in terms of the implementation of quality management system.

Responsibilities:

• Provide oversight for collecting laws and regulations related to medical device distribution,  and implementing dynamic management; guiding relevant departments analysis and improve JJMS quality management system to ensure the compliance with laws and regulations.
• Responsible for HCS external manufacturing oversight for quality operations implementation and lead the quality operations organization for HCS
• Lead Q&C function on realizing company strategy from Quality & Compliance function.
• Be responsible for establishing a professional Q&C team to support business and quality management. Ensure members get appropriate training to function properly. It includes HCC, and others
• Ensure good succession planning for all key position, talent development plan and drive high team engagement. Engage and develop people and talent, to build a united & high-performance team.
• Establish and arrange the management review of the QMS.
• Organize the review and inspection of the qualification of medical device suppliers, products and buyers.
• Provide oversight for confirming the non-conformance medical devices and implementing supervision on the processing of non-conformance medical devices.
• Provide oversight for the investigation, processing and reporting of quality complaints and quality accidents of medical devices and management of medical device recalls.
• Organize the verification and calibration of relevant facilities and equipment.
• Organize the review on the storage and transportation conditions and quality assurance ability of the third party logistic enterprise.
• Organize the review on the transportation conditions and quality assurance ability of the transportation supplier.
• Organize quality management training.
• Other responsibilities defined in written procedures or quality manual.
• Responsible for the organization and implementation of medical device risk consultation meeting.
• Provide oversight on EHS & ISO14001 compliance
• Fulfill other tasks assigned.

Requirements

• Master Degree on Science or pharmaceutical/medical device or related subjects.
• >12 year experience in quality management or in medical device or pharmaceutical.
• Strong working experience with China GMP for Medical Devices manufacturing
• Successfully managed China local manufacturing QA department and or significant QA project.
• Strong leadership and be able to dead and coach subordinator
• English fluent in reading, writing, oral, listening.