Bioseal GM Guangzhou
Ensure compliance with relevant laws and regulations, meet customer/patient needs, promote business growth, and support company's continuous development.
The following are the responsibilities and duties of this position in accordance with applicable federal, state, and local laws/regulations, as well as Johnson & Johnson's procedures and guidelines:
1. As the primary responsible person for drug production and drug marketing authorization, medical device holder, legal representative of the company, fully responsible for daily management of the enterprise. Ensure that the company achieves quality objectives and follows GMP and GVP requirements for drug production/operation and relevant laws and regulations for medical device production/operation, in compliance with drug GMP and its appendix, medical device GMP and its appendix, GVP, device adverse events, and related regulations for medical device production/operation.
2. As the general manager and legal representative of the company: responsible for managing company's operational profit and financial status, ensuring the effective operation of the company, maintaining the supply of products in the Chinese market, organizing the development of main production plans and material plans to meet J&J's and Chinese regulatory registration requirements.
ü Based on J&J credo and company strategy, design the organization structure, communicate new company strategy and culture.
ü Develop supply chain and quality management strategies.
ü Organize the development of company's quality policy and quality objectives.
ü Establish a corporate quality management system in accordance with Chinese regulations.
ü Promote the importance of meeting customer and legal/regulatory requirements for the company's survival and development through meetings, communications, trainings, etc.
ü Ensure the involvement and responsibility of personnel at different levels, as well as suppliers and distributors.
ü Fully responsible for pharmacovigilance activities. Appoint a pharmacovigilance responsible person, provide sufficient personnel with appropriate qualifications, and provide necessary resources to ensure the effective operation of the pharmacovigilance system and the achievement of quality objectives.
3. As the responsible person for the pharmaceutical company:
ü Responsible for drug quality, fully responsible for daily management of the enterprise.
ü Provide necessary resources to ensure that the company achieves quality objectives and produces drugs in accordance with requirements. Plan, organize, and coordinate accordingly, ensuring the independent performance of the quality management department.
ü Fully responsible for pharmacovigilance activities. Appoint a pharmacovigilance responsible person, provide sufficient personnel with appropriate qualifications, and provide necessary resources to ensure the effective operation of the pharmacovigilance system and the achievement of quality objectives.
ü Delegate management responsibilities for drug operations to drug distribution companies (distributors).
4. As the responsible person for the medical device company:
ü Responsible for the quality of medical device products.
ü Organize the development of the company's quality policy and quality objectives.
ü Ensure the availability of human resources, infrastructure, and working environment necessary for the effective operation of the quality management system.
ü Organize the implementation of management reviews, conduct regular assessments of the quality management system's performance, and pursue continuous improvement.
ü Ensure that the company organizes production in accordance with legal requirements, regulations, and rules.
ü Appoint a quality management representative in accordance with local regulations.
ü At the same time, as the medical device registration holder, assume the primary responsibility for monitoring medical device adverse events:
ü Establish a system for monitoring medical device adverse events.
ü Provide sufficient personnel with proper qualifications to engage in the monitoring of medical device adverse events.
ü Proactively collect, report, investigate, analyze, and evaluate medical device adverse events, take timely and effective measures to control risks and release risk information.
ü Conduct ongoing research on the safety of marketed medical devices, carry out risk assessments and key monitoring activities as required, and submit relevant reports.
ü Actively cooperate with drug regulatory authorities and monitoring institutions in conducting monitoring activities related to medical device adverse events.
5. As the first person responsible for enterprise safety production management: fully responsible for the implementation of J&J's EH&S standards and the execution of relevant national and local environmental, safety, and health laws and regulations.
ü Establish and implement a safety production responsibility system, strengthen the standardization of safety production.
ü Organize the development and implementation of safety production regulations and operating procedures.
ü Organize the development and implementation of safety production education and training plans.
ü Ensure the effective implementation of safety production investment.
ü Establish and implement a dual prevention mechanism for safety risk classification control and potential hazard investigation and governance, supervise and inspect safety production work, timely eliminate potential safety production accidents.
ü Organize the development and implementation of emergency response plans for production safety accidents.
ü Report production safety accidents in a timely and truthful manner.
6. Quality Management: Implement relevant regulations and standards, fulfill quality and validation programs and procedures, establish a corporate quality management system in accordance with Chinese GMP standards, conduct management reviews, conduct regular assessments of the quality management system's performance, and pursue continuous improvement. Strengthen daily quality reviews and action plans to ensure the achievement of quality objectives and compliance with GMP requirements for production, ensuring that the quality management system obtains necessary resources.
7. Financial: Comply with the requirements of company SOPs, strengthen control while providing sufficient resources to meet cash flow and velocity requirements of the company, establish cost accounting control to enhance budget management.
8. Talent and Culture: Establish organizational capabilities through recruitment and talent development strategies, fully implement J&J's HR policies and management regulations, cultivate internal talent, implement succession plans and strategies, strengthen the company's core competitiveness through operations, and promote the J&J credo and compliance culture.
9. Product Development: Develop R&D and clinical research strategies, implement sustainable R&D and innovation projects for hospital channels.
10. Marketing: Support market promotion and channel requirements to better understand customer needs.
11. Government, Public Affairs, and Communications: Develop and implement company strategies for government and public affairs and communication, promote cooperation with local government departments.
12. Legal Affairs: Responsible for establishing and optimizing company's legal system, managing and maintaining the company's intellectual property, ensuring compliance and legality of company operations.
13. Regulatory Affairs Department: Responsible for product and new product regulatory registration and application for relevant certificates, communicate with drug regulatory authorities to ensure regulatory compliance.
14. Procurement Department: Develop company's procurement management system and strategies, responsible for the procurement of inventory and non-inventory related products and services, ensuring product supply and operations.
15. Engineering Department: Develop and implement investment plans for production equipment and power equipment in the factory, continuously improve the equipment preventive maintenance management system, ensure the equipment functions as expected, and improve the stability of the power system.
16. Production Department: Continuously improve production management system, ensure structured activities, compliance, and continuous improvement in production efficiency and cost reduction, responsible for process support during production.
17. Planning and Logistics Department: Responsible for planning, customer service, sales, logistics, and warehousing management, ensuring safe, continuous, and stable production and supply of products.
18. Human Resource Management Responsibilities:
ü Guide employees and understand the company's development direction.
ü Help employees grow by providing resources to help them acquire skills and bring value in their work.
ü Care for employees, enabling them to enjoy a better quality of life and achieve harmonious win-win growth of employees and company.
19. Compliance with company credo and regulations:
ü Strictly follow operational safety requirements and participate in daily fire prevention and security work.
ü Report any identified accident hazards immediately.
ü Follow relevant safety procedures in case of emergency accidents.
ü Responsible for conveying business-related issues or opportunities to the next level of management.
ü For those who supervise or manage employees, if applicable, responsible for ensuring that subordinates comply with all company guidelines related to health, safety, and environmental practices, and that all necessary resources are available and in good condition.
ü Responsible for ensuring that individuals and the company comply with all federal, state, local, and company regulations, policies, and procedures.
ü Perform other necessary duties.