Be responsible for the overall quality activities, including purchasing controls, associated with suppliers impacting the local site
Lead development, continuous improvement and implementation of purchasing control processes for responsible external manufacturers that meet regulatory requirements and align with J&J MD standards.
Recruit, develop and manage a high performing source quality team to achieve the group’s objectives, if applicable.
Provide Source Quality Engineering support to direct material and external manufacturers including inspection technique, product non-conformances, verification/validation activities, CAPA and change management.
Ensure effective and timely investigation and closure of all CAPA’s, Non Conformances, complaints, product issues.
Lead Source Quality input to site management reviews and product/process escalations.
Supports third party assessments at both External Manufacturers and sub-tier suppliers.
Provide Quality Leadership in support of External Manufacturing Outsourcing programs and product transfers
Partner with site Management teams to meet site Source Quality related objectives
Provide Source Quality input to and attend quality/business reviews as required
Responsible for ensuring the supplier audit schedule is achieved
Drive a standardised approach by chairing Supplier Management Committee meetings, Supplier Performance Monitoring and Joint Supplier Collaboration sessions.
Maintain and control the approved supplier list for responsible sites.
Maintain and control company SOPs in support of initial supplier approval and continuous supplier evaluation and in compliance with J&J MD Source Quality requirements
Maintain supplier management documentation and records to ensure they are complete and current
Promote continuous improvement and Process Excellence activities within the Source Quality Management group
Work to ensure supplier quality engineering resources are prioritized in support of business and quality aims
Actively drive all defined Direct Material and External Manufacturing Quality Systems goals and objectives.
Design and validate Quality System processes where appropriate
Participate in design evaluations where appropriate
Resolve problems and eliminate constraints to ensure project and supply targets are met.
Generate Quality metrics on supplier performance and establish measures to monitor quality
Maintain standards of housekeeping and GMP requirements
Represent the Supply Process Quality Assurance function as required by management
Ensure that all Health, Safety and Environmental requirements are fulfilled.
Maintain detailed and accurate records of all activities
A minimum of a Bachelor’s degree in engineering/scientific or associated relevant technical / engineering discipline is required. An Advanced degree in engineering/scientific or discipline is preferred. A minimum of 6 years progressive experience in a regulated industry like Medical Devices, Pharma and/or Consumer is required. Previous work experience with Suppliers is preferred. Demonstrated knowledge of business impact of compliance issues and risk management is required. Experience in leadership roles involving project management, problem solving and technical projects is required. This individual is required to possess high performing skills in negotiating and influencing decision makers, decision making skills, communication skills, judgement, tact and leadership skills.
China-Anhui-Suzhou-No. 299, Changyang Street, Suzhou Industrial Park
Johnson & Johnson Medical Suzhou Ltd. (7054)