Business Quality Director-00000QDI
Description
Basic Purpose
The BQ Director has overall Quality oversight and responsibility for the China Consumer Sector businesses, ensuring quality and compliance during the entire life cycle of the commercialized product.
Scope of Role
Lead the robust implementation and review of the Quality Management system for China Consumer businesses. Ensure ongoing compliance of all J&J Consumer products marketed in China. Includes all products marketed by the Consumer sector for all regulatory classes (ex Cosmetics, device, OTC).
Implement the J&J Quality Management System while ensuring simultaneous compliance with local regulations: include NPI’s, product release activities as applicable, appropriateness of product information to be used by CCC, commercialization practices, artwork generation, complaints management, event/issue management, training and qualification on GXP’s processes for all members of the LOC.
Be the Primary Quality partner for the business /commercial organizations, R&D and NPI commercialization teams for products going into the local market. Partner with cross functional technical teams to ensure compliance of NPDs with local regulations and continuing compliance of actual products with regulatory commitments and dossiers and subsequent regulatory change.
Continuously monitor and improve quality systems & procedures to ensure full compliance to Quality Policy, Enterprise standards, WW Procedures and Guidelines. Participate in global and regional procedures reviews to ensure applicability for LOC execution, proper gap assessment and mitigation plan execution.
Interact with Make, Source and Commercial partners to lead product risk management process. Ensure appropriate risk assessment and management for products
Lead Management review for LOC, Product review, Quality review board, Product discontinuations and Field Actions for local company.
Ensure implementation of the end-to-end complaints vigilance process. Lead the periodic review of complaints & adverse events with the appropriate local and regional stakeholders as defined in the QMS, and track needed actions to address adverse trends.
Keep country management aware of Quality and compliance related issues/systems through periodic Management Review Process and issue escalation.
Detect and escalate issues or new regulations requiring changes in the business processes. Incorporate into the country Quality System.
Lead preparedness of local company for audits, issue resolutions with Local Authorities and company management. Lead investigations, corrective and preventive actions for issues detected potentially affecting the products or to improve compliance with regulations
Manage and develop organization. Be responsible for budget, staffing, career planning, training & development & providing for a safe & pleasant working environment for all quality employees. Ensure acceptable behavior and performance, as well as implementation of Leadership Imperatives across the organization.
Partner with CLS and Source Q&C for the reliable supply from relabeling/repacking service providers to the marketing company.
Partner with R&D Q&C to ensure high quality products are transitioned effectively from development to the market.
Review and approval of any marketing related promotional materials and their suppliers.
Qualifications
Key Measures This position will be measured primarily on:
Achievement and continuing improvement on GOC metrics.
Ensure organization readiness for internal / external audit, and on time / on quality audit action plan closure.
Continuously improve Credo survey results, develop effective actions to address top concerns.
Develop organization talent pipeline and provide adequate resource support to ensure delivery of business goals.
Education and Qualification
The candidate must have a Bachelor or equivalent degree in Science or Engineering (ex. Pharmacy, Pharmaceutical engineering, Microbiology, Health Science, Chemistry). A master’s degree in relevant fields such as Business or Science/Engineering is preferred.
At least 12 years of industry experience in a quality, supply chain or technical field in a consumer goods/OTC/device company is needed to be successful. The candidate must also have experience working in a cross functional team environment and must have performed team leader/functional leader role to be successful in this role.
Excellent communication, analytical and leadership/people development skills and experience.
Primary Location:Asia Pacific-China-Shanghai-Shanghai
Organization: Johnson & Johnson (China) Ltd. (7047)
Job Function: Quality (Generalist)
Description
Basic Purpose
The BQ Director has overall Quality oversight and responsibility for the China Consumer Sector businesses, ensuring quality and compliance during the entire life cycle of the commercialized product.
Scope of Role
Lead the robust implementation and review of the Quality Management system for China Consumer businesses. Ensure ongoing compliance of all J&J Consumer products marketed in China. Includes all products marketed by the Consumer sector for all regulatory classes (ex Cosmetics, device, OTC).
Implement the J&J Quality Management System while ensuring simultaneous compliance with local regulations: include NPI’s, product release activities as applicable, appropriateness of product information to be used by CCC, commercialization practices, artwork generation, complaints management, event/issue management, training and qualification on GXP’s processes for all members of the LOC.
Be the Primary Quality partner for the business /commercial organizations, R&D and NPI commercialization teams for products going into the local market. Partner with cross functional technical teams to ensure compliance of NPDs with local regulations and continuing compliance of actual products with regulatory commitments and dossiers and subsequent regulatory change.
Continuously monitor and improve quality systems & procedures to ensure full compliance to Quality Policy, Enterprise standards, WW Procedures and Guidelines. Participate in global and regional procedures reviews to ensure applicability for LOC execution, proper gap assessment and mitigation plan execution.
Interact with Make, Source and Commercial partners to lead product risk management process. Ensure appropriate risk assessment and management for products
Lead Management review for LOC, Product review, Quality review board, Product discontinuations and Field Actions for local company.
Ensure implementation of the end-to-end complaints vigilance process. Lead the periodic review of complaints & adverse events with the appropriate local and regional stakeholders as defined in the QMS, and track needed actions to address adverse trends.
Keep country management aware of Quality and compliance related issues/systems through periodic Management Review Process and issue escalation.
Detect and escalate issues or new regulations requiring changes in the business processes. Incorporate into the country Quality System.
Lead preparedness of local company for audits, issue resolutions with Local Authorities and company management. Lead investigations, corrective and preventive actions for issues detected potentially affecting the products or to improve compliance with regulations
Manage and develop organization. Be responsible for budget, staffing, career planning, training & development & providing for a safe & pleasant working environment for all quality employees. Ensure acceptable behavior and performance, as well as implementation of Leadership Imperatives across the organization.
Partner with CLS and Source Q&C for the reliable supply from relabeling/repacking service providers to the marketing company.
Partner with R&D Q&C to ensure high quality products are transitioned effectively from development to the market.
Review and approval of any marketing related promotional materials and their suppliers.
Qualifications
Key Measures This position will be measured primarily on:
Achievement and continuing improvement on GOC metrics.
Ensure organization readiness for internal / external audit, and on time / on quality audit action plan closure.
Continuously improve Credo survey results, develop effective actions to address top concerns.
Develop organization talent pipeline and provide adequate resource support to ensure delivery of business goals.
Education and Qualification
The candidate must have a Bachelor or equivalent degree in Science or Engineering (ex. Pharmacy, Pharmaceutical engineering, Microbiology, Health Science, Chemistry). A master’s degree in relevant fields such as Business or Science/Engineering is preferred.
At least 12 years of industry experience in a quality, supply chain or technical field in a consumer goods/OTC/device company is needed to be successful. The candidate must also have experience working in a cross functional team environment and must have performed team leader/functional leader role to be successful in this role.
Excellent communication, analytical and leadership/people development skills and experience.
Primary Location:Asia Pacific-China-Shanghai-Shanghai
Organization: Johnson & Johnson (China) Ltd. (7047)
Job Function: Quality (Generalist)
