MANAGER, QUALITY SYSTEMS ASIA PACIFIC-8156141029
Description
Quality Management System Responsibilities/Competencies:
- Will participate on project, learn and become subject matter expert on electronic Document Management system and process being deployed to LOCs and CLS locations in support of Business Quality initiative.
- Along with business process and application owner, responsible for strategic development / integration of document management processes and systems to form a holistic document control system. Upon successful deployment, ensures ongoing maintenance of processes, procedures, training materials, metrics and support for operations in Business Quality and associated end users.
- Acts as a steward of the system and serves as a direct support resource to regional business personnel supporting the document control system. Responsible for compliance and application monitoring, communication distribution and facilitating regular forums for supported users.
- Provides overall System Administration for the document control system. Acts as a liaison to the business for resolving technical issues and maintaining system Master Data in accordance with the global strategy. Performs system testing and validation release activities in accordance with defined SDLC (system development lifecycle requirements) as needed.
- Provides training to regional business resources as well as audit support and user account management for assigned locations.
- Works with business owner to define integrated future state roadmap for the Document Management Quality System representing the business. Partners with QS, business and IT partners to recognize, plan and deliver solutions in accordance with process and data standardization for end users.
Professional Competencies:
- Operational Excellence:
- Displays in depth knowledge of Analytics & Problem Solving and Decision Making - Partners with the business to optimize process changes in the quality system. Able to identify the problems and root causes of issues when delivering the strategy for the business solution. Demonstrates ability to make tough calls in service of the business.
- Regulatory Essentials:
- Possesses regulatory and business knowledge to champion improvements to the quality systems.
- Ability to effectively apply knowledge of key business functions and processes in compliance with J&J Quality Policy & Standards.
- Business Fundamentals:
- Aptitude for learning and applying new technology, software.
- Displays knowledge and effective utilization of project management tools and processes.
- Actively leverages and shares resources, processes and best practices across the business. Establishes mutually beneficial objectives and accountabilities to achieve goals. Builds consensus and impacts outcomes with limited authority. Sponsors integration initiatives that align with the business objectives.
- Business Partnering:
- Serves as champion for Change Management - consistently delivering business solutions driving customer (organizational) value while engaging all stakeholders. Is a role model for cooperation and teamwork. Works to ensure alignment and communication of objectives across functions.
- Demonstrates global business and organizational savvy.
This is intended to be a general job description and should not be construed as all inclusive.
KEY RESPONSIBILITIES:
Strategy (5%):
Employs the learnings obtained from industry insight and cross-company opportunities to establish a global vision for improved PLM compliance across the quality system that balances compliance risk with business objectives. Works with business partners to ensure alignment of quality system initiatives with strategic business direction. Creates and implements strategic direction based on commercial operations and quality system synergies. Collaborates with site and global business functions to establish the vision and strategies for the development and integration of quality systems processes and applications in line with Regulatory requirements.
Leadership (35%):
Serves as a steward of the document management system to the greater organization. Provides leadership and ensures operational success within assigned region, with an emphasis on continuous improvement, and customer satisfaction. Provides balanced leadership and management of quality and compliance risks with business needs. Develops and fosters an environment of innovative thinking and learning, through project management, benchmarking methods, training programs, the use of Process Excellence tools, and monitoring of progress. Removes barriers to support to ensure user success and ensures timely resolution of technical issues.
Tactics (20%):
Collaborates with location and global business functions to integrate and assure implementation of effective quality systems strategies that support the business strategies. Ensures the integration of risk management with current and emerging processes. Develops and leads innovative initiatives to improve quality system / business performance. Develops and monitors process performance metrics. Assists with the management of the document management system enhancement request and delivery process.
Compliance (35%):
Communicates expertise and guidance on relevant regulations, directives on standards and industry guidance related to quality system design and operation. Responsible for compliance and application monitoring for the document management system to ensure the system and process is used in compliance with procedures and standards. Maintains system support materials, provides location audit support and trains business administrators on use of the document management system and process.
Core Business (5%):
For Quality Systems, participate and assist with developing and driving budgets, organizational structure, and business requirements to accommodate business needs as requested.
The Quality Systems Manager is a member of a globally-based, virtual organization, must be able to work independently and make decisions to support users and troubleshoot issues within assigned region, must be able to interact and communicate with more senior levels of management as well as all levels of users located in LOC or CLS sites, must occasionally interact with system managers in other regions requiring some flexibility in scheduling meetings.
Qualifications
REQUIRED:
- Bachelor's Degree; preferably in Life Science / Technical, or equivalent experience
- ASQ, PMI, or PE certification
- Mgr: At least 5 years of experience in a regulated medical/pharmaceutical industry (Pharmaceutical, Medical Devices, Diagnostics or Consumer products)
- Working knowledge of the business environment inside a quality organization, across various roles (e.g., quality operations, quality control, quality systems, quality assurance, etc.).
- Demonstrated knowledge of applicable regulations within the US (FDA) and outside the US (e.g., EMEA ICH Q8, 9, 10).
DESIRED:
Direct working knowledge of the business environment outside of the quality organization within the commercial Local Operating Company or Distribution Center.
JOB SPECIFIC COMPETENCIES/ SKILLS REQUIRED:
1. Team collaboration, troubleshooting and coaching skills.
2. Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style. Must be able to read, write and speak English.
3. Results-driven leader who commits to stretch goals and delivers results. Sound business skills, balanced decision-maker.
4. Ability to build and nurture strong, positive relationships with business leadership and partners in J&J Quality Systems, Business Quality, IT, Regulatory Affairs, Medical Affairs, Medical Safety, Marketing and other Quality functional groups.
5. Demonstrated understanding of regulatory requirements that impact Quality Systems specifically, and the commercial organization more broadly.
6. Role model for Global Leadership Profile behaviors.
LOCATION: Asia Pacific
J2W: LI ASPAC
Primary Location:Asia Pacific-Singapore-Singapore-Singapore
Organization: Johnson & Johnson Pte. Ltd. (8435)
Job Function: Quality Systems
Description
Quality Management System Responsibilities/Competencies:
- Will participate on project, learn and become subject matter expert on electronic Document Management system and process being deployed to LOCs and CLS locations in support of Business Quality initiative.
- Along with business process and application owner, responsible for strategic development / integration of document management processes and systems to form a holistic document control system. Upon successful deployment, ensures ongoing maintenance of processes, procedures, training materials, metrics and support for operations in Business Quality and associated end users.
- Acts as a steward of the system and serves as a direct support resource to regional business personnel supporting the document control system. Responsible for compliance and application monitoring, communication distribution and facilitating regular forums for supported users.
- Provides overall System Administration for the document control system. Acts as a liaison to the business for resolving technical issues and maintaining system Master Data in accordance with the global strategy. Performs system testing and validation release activities in accordance with defined SDLC (system development lifecycle requirements) as needed.
- Provides training to regional business resources as well as audit support and user account management for assigned locations.
- Works with business owner to define integrated future state roadmap for the Document Management Quality System representing the business. Partners with QS, business and IT partners to recognize, plan and deliver solutions in accordance with process and data standardization for end users.
Professional Competencies:
- Operational Excellence:
- Displays in depth knowledge of Analytics & Problem Solving and Decision Making - Partners with the business to optimize process changes in the quality system. Able to identify the problems and root causes of issues when delivering the strategy for the business solution. Demonstrates ability to make tough calls in service of the business.
- Regulatory Essentials:
- Possesses regulatory and business knowledge to champion improvements to the quality systems.
- Ability to effectively apply knowledge of key business functions and processes in compliance with J&J Quality Policy & Standards.
- Business Fundamentals:
- Aptitude for learning and applying new technology, software.
- Displays knowledge and effective utilization of project management tools and processes.
- Actively leverages and shares resources, processes and best practices across the business. Establishes mutually beneficial objectives and accountabilities to achieve goals. Builds consensus and impacts outcomes with limited authority. Sponsors integration initiatives that align with the business objectives.
- Business Partnering:
- Serves as champion for Change Management - consistently delivering business solutions driving customer (organizational) value while engaging all stakeholders. Is a role model for cooperation and teamwork. Works to ensure alignment and communication of objectives across functions.
- Demonstrates global business and organizational savvy.
This is intended to be a general job description and should not be construed as all inclusive.
KEY RESPONSIBILITIES:
Strategy (5%):
Employs the learnings obtained from industry insight and cross-company opportunities to establish a global vision for improved PLM compliance across the quality system that balances compliance risk with business objectives. Works with business partners to ensure alignment of quality system initiatives with strategic business direction. Creates and implements strategic direction based on commercial operations and quality system synergies. Collaborates with site and global business functions to establish the vision and strategies for the development and integration of quality systems processes and applications in line with Regulatory requirements.
Leadership (35%):
Serves as a steward of the document management system to the greater organization. Provides leadership and ensures operational success within assigned region, with an emphasis on continuous improvement, and customer satisfaction. Provides balanced leadership and management of quality and compliance risks with business needs. Develops and fosters an environment of innovative thinking and learning, through project management, benchmarking methods, training programs, the use of Process Excellence tools, and monitoring of progress. Removes barriers to support to ensure user success and ensures timely resolution of technical issues.
Tactics (20%):
Collaborates with location and global business functions to integrate and assure implementation of effective quality systems strategies that support the business strategies. Ensures the integration of risk management with current and emerging processes. Develops and leads innovative initiatives to improve quality system / business performance. Develops and monitors process performance metrics. Assists with the management of the document management system enhancement request and delivery process.
Compliance (35%):
Communicates expertise and guidance on relevant regulations, directives on standards and industry guidance related to quality system design and operation. Responsible for compliance and application monitoring for the document management system to ensure the system and process is used in compliance with procedures and standards. Maintains system support materials, provides location audit support and trains business administrators on use of the document management system and process.
Core Business (5%):
For Quality Systems, participate and assist with developing and driving budgets, organizational structure, and business requirements to accommodate business needs as requested.
The Quality Systems Manager is a member of a globally-based, virtual organization, must be able to work independently and make decisions to support users and troubleshoot issues within assigned region, must be able to interact and communicate with more senior levels of management as well as all levels of users located in LOC or CLS sites, must occasionally interact with system managers in other regions requiring some flexibility in scheduling meetings.
Qualifications
REQUIRED:
- Bachelor's Degree; preferably in Life Science / Technical, or equivalent experience
- ASQ, PMI, or PE certification
- Mgr: At least 5 years of experience in a regulated medical/pharmaceutical industry (Pharmaceutical, Medical Devices, Diagnostics or Consumer products)
- Working knowledge of the business environment inside a quality organization, across various roles (e.g., quality operations, quality control, quality systems, quality assurance, etc.).
- Demonstrated knowledge of applicable regulations within the US (FDA) and outside the US (e.g., EMEA ICH Q8, 9, 10).
DESIRED:
Direct working knowledge of the business environment outside of the quality organization within the commercial Local Operating Company or Distribution Center.
JOB SPECIFIC COMPETENCIES/ SKILLS REQUIRED:
1. Team collaboration, troubleshooting and coaching skills.
2. Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style. Must be able to read, write and speak English.
3. Results-driven leader who commits to stretch goals and delivers results. Sound business skills, balanced decision-maker.
4. Ability to build and nurture strong, positive relationships with business leadership and partners in J&J Quality Systems, Business Quality, IT, Regulatory Affairs, Medical Affairs, Medical Safety, Marketing and other Quality functional groups.
5. Demonstrated understanding of regulatory requirements that impact Quality Systems specifically, and the commercial organization more broadly.
6. Role model for Global Leadership Profile behaviors.
LOCATION: Asia Pacific
J2W: LI ASPAC
Primary Location:Asia Pacific-Singapore-Singapore-Singapore
Organization: Johnson & Johnson Pte. Ltd. (8435)
Job Function: Quality Systems