Senior Manager ESIQ-Supplier Quality-00000LJN
Description
Position Summary:
Supplier quality lead provides Quality Assurance, Compliance and Technical Support for Strategic API External Manufacturers in China. Provide QA support for technology transfer and improvement of existing manufacturing processes.
Contribute to the overall development, implementation and execution of quality systems in support of the commercial production of Janssen products at strategic External manufacturers. Ensures pro-active and continuous compliance with applicable Health Authority regulations and J&J standards, including effective risk management.
Conducts investigations, performs audits, collects data, analyze trends, and prepare reports as required. Escalates issues as appropriate to Senior Management and supports the Management Reviews. Works closely with Global Procurement and other Quality Assurance functions.
Lead/Leadership: Provides leadership and ensures the success of external manufacturer qualification and monitoring regionally, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability. Provides balanced management of quality and compliance risks with business needs.
With focus on Quality activities, develops and fosters an environment of innovative thinking and learning at the external manufacturer, through project management, benchmarking methods, training programs, the use of Process Excellence tools, and monitoring of progress.
Assists the external manufacturer in defining Quality Strategies and Organizational Development.
Effectuates and permanently maintains inspection readiness at the external manufacturers and suppliers. Including on site representation during regulatory inspections and audits. And drives development of corrective actions plans, as needed.
Shape: Works with business partners and external manufacturer to ensure alignment of supplier qualification/monitoring activities with strategic business direction.
Ensures that the quality process and systems to support Janssen product manufacturing are adhered to and maintained. Communicates expertise and guidance on relevant regulations, directives, J&J standards and industry guidance related to quality systems design and operation.
Defines and monitors adherence to metrics for Quality with the external manufacturer.
Deliver: Responsible and accountable for the quality and reliability of products produced at the external manufacturer. Coordinates and executes the Supplier Quality Management activities. This includes continuous oversight and management of:
- Quality activities during manufacturing and quality control (including validations, issue management, trouble shooting, change management, supplier and material management).
- Execution of monitoring and auditing activities (including creation of quality agreements)
- Assessing quality systems and recommending improvements in order to enhance quality
- Reporting of quality activities, and as needed escalation of issues to senior JSC management
Coordinates or executes quality activities in support of New product Introductions (through upscaling and launch), process improvements and significant changes.
Communicates external manufacturer status to support management review processes.
Connect
Lead frequent interactions with strategic external manufacturers, up to and including Sr. Management levels, for the purpose of driving reliability, continuous improvement, Risk management, Quality strategies and Quality System compliance.
Partners with Global Procurement and business partners to effectively manage external manufacturers. Including participation in Top to Top meetings and supplier business review meetings.
Remaining current with regional and global Health Authority regulations, guidelines and quality practices associated with cGMP and API manufacturing.
Qualifications
Minimum Bachelor's Degree Required. Advanced degree (MS, MBA) is preferred. An 8-12 years experience in Pharmaceutical or Biotechnology cGMP environment is required. Experience in drugs or biologics quality management or manufacturing are essential to success. Experience in External Manufacturing, Technology Transfers, Quality Event Management and Quality System Development is required. Experience in presenting issues to all levels of the organization is required.
Ability to manage Quality Systems and provide cGMP compliance support to External Manufacturers is required. Including proven ability to manage Regulatory inspections and Heath Authority exposure.
Demonstrated experience with API manufacturing and Quality control is preferred. Including underdstanding of typical unit operations, process equipment and analytical techniques (HPLC, GC, IR, wet chemistry testing, …).
Demonstrated experience with quality activities during API process development, upscaling, validation and launch is preferred. Including understanding of filing requirements and regulatory support.
Proficiency in computer applications such as the MS Office suite is preferred.
Interpersonal skills are required to build long term relationships, influence up and down, negotiate acceptable outcomes, multiple disciplinary, cross-cultural environments in External Manufacturers and J&J.
Demonstrates refined skills in the following Global Leadership areas: Integrity and Credo-based Actions; Strategic Thinking; Big Picture Orientation with Attention to Detail; Intellectual Curiosity; Collaboration and Teaming; Sense of Urgency; Prudent Risk-taking; Self-awareness and Adaptability; Results and Performance Driven. Ability to travel a minimum of 40% is required. Position will be based in Hangzhou China, but business trips will be required, regionally within Asia and globally (when needed). Very frequent on site presence at external manufacturers will be required.
Fluent in English and Mandarin.
Primary Location:Asia Pacific-China-Zhejiang-Hangzhou
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Travel:Yes, 50 % of the Time
Job Function: Quality Assurance
Description
Position Summary:
Supplier quality lead provides Quality Assurance, Compliance and Technical Support for Strategic API External Manufacturers in China. Provide QA support for technology transfer and improvement of existing manufacturing processes.
Contribute to the overall development, implementation and execution of quality systems in support of the commercial production of Janssen products at strategic External manufacturers. Ensures pro-active and continuous compliance with applicable Health Authority regulations and J&J standards, including effective risk management.
Conducts investigations, performs audits, collects data, analyze trends, and prepare reports as required. Escalates issues as appropriate to Senior Management and supports the Management Reviews. Works closely with Global Procurement and other Quality Assurance functions.
Lead/Leadership: Provides leadership and ensures the success of external manufacturer qualification and monitoring regionally, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability. Provides balanced management of quality and compliance risks with business needs.
With focus on Quality activities, develops and fosters an environment of innovative thinking and learning at the external manufacturer, through project management, benchmarking methods, training programs, the use of Process Excellence tools, and monitoring of progress.
Assists the external manufacturer in defining Quality Strategies and Organizational Development.
Effectuates and permanently maintains inspection readiness at the external manufacturers and suppliers. Including on site representation during regulatory inspections and audits. And drives development of corrective actions plans, as needed.
Shape: Works with business partners and external manufacturer to ensure alignment of supplier qualification/monitoring activities with strategic business direction.
Ensures that the quality process and systems to support Janssen product manufacturing are adhered to and maintained. Communicates expertise and guidance on relevant regulations, directives, J&J standards and industry guidance related to quality systems design and operation.
Defines and monitors adherence to metrics for Quality with the external manufacturer.
Deliver: Responsible and accountable for the quality and reliability of products produced at the external manufacturer. Coordinates and executes the Supplier Quality Management activities. This includes continuous oversight and management of:
- Quality activities during manufacturing and quality control (including validations, issue management, trouble shooting, change management, supplier and material management).
- Execution of monitoring and auditing activities (including creation of quality agreements)
- Assessing quality systems and recommending improvements in order to enhance quality
- Reporting of quality activities, and as needed escalation of issues to senior JSC management
Coordinates or executes quality activities in support of New product Introductions (through upscaling and launch), process improvements and significant changes.
Communicates external manufacturer status to support management review processes.
Connect
Lead frequent interactions with strategic external manufacturers, up to and including Sr. Management levels, for the purpose of driving reliability, continuous improvement, Risk management, Quality strategies and Quality System compliance.
Partners with Global Procurement and business partners to effectively manage external manufacturers. Including participation in Top to Top meetings and supplier business review meetings.
Remaining current with regional and global Health Authority regulations, guidelines and quality practices associated with cGMP and API manufacturing.
Qualifications
Minimum Bachelor's Degree Required. Advanced degree (MS, MBA) is preferred. An 8-12 years experience in Pharmaceutical or Biotechnology cGMP environment is required. Experience in drugs or biologics quality management or manufacturing are essential to success. Experience in External Manufacturing, Technology Transfers, Quality Event Management and Quality System Development is required. Experience in presenting issues to all levels of the organization is required.
Ability to manage Quality Systems and provide cGMP compliance support to External Manufacturers is required. Including proven ability to manage Regulatory inspections and Heath Authority exposure.
Demonstrated experience with API manufacturing and Quality control is preferred. Including underdstanding of typical unit operations, process equipment and analytical techniques (HPLC, GC, IR, wet chemistry testing, …).
Demonstrated experience with quality activities during API process development, upscaling, validation and launch is preferred. Including understanding of filing requirements and regulatory support.
Proficiency in computer applications such as the MS Office suite is preferred.
Interpersonal skills are required to build long term relationships, influence up and down, negotiate acceptable outcomes, multiple disciplinary, cross-cultural environments in External Manufacturers and J&J.
Demonstrates refined skills in the following Global Leadership areas: Integrity and Credo-based Actions; Strategic Thinking; Big Picture Orientation with Attention to Detail; Intellectual Curiosity; Collaboration and Teaming; Sense of Urgency; Prudent Risk-taking; Self-awareness and Adaptability; Results and Performance Driven. Ability to travel a minimum of 40% is required. Position will be based in Hangzhou China, but business trips will be required, regionally within Asia and globally (when needed). Very frequent on site presence at external manufacturers will be required.
Fluent in English and Mandarin.
Primary Location:Asia Pacific-China-Zhejiang-Hangzhou
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Travel:Yes, 50 % of the Time
Job Function: Quality Assurance