ASSOC DIR, MALAYSIA BIZ QUALITY HEAD-3411140829
Description
The Business Quality Services Head of One SEA Business Quality organization reports solid line to the One SEA Business Quality Senior Director, and connects with each Sectors and Enterprise Quality Systems. The individual is responsible for building and leading a cross-sector Business Quality Services organization for One SEA. The role requires partnership and building of alliances with the SEA Country Business Quality Heads and other stakeholders to execute core Quality Systems and processes for the Local Operating Companies (LOCs).
- Contributes to maintenance, compliance and improvement of the Business Quality Management System in accordance with J&J Enterprise One Quality System and associated Sector standards throughout the SEA organization. Establishes the strategy and accountable for execution of tactical initiatives to comply with local government regulatory requirement on the Quality Systems that it owns.
- Oversees the provision of functional and technical support, training as needed to ensure the integrity of the standards deployment and provide knowledge and insight of emerging trends within the Business Quality Services organization in collaboration with Asia-Pacific.
- Partner with Enterprise and APAC Experts in the development of common Best Practice business processes through the leveraging of the system/process knowledge, experience, internal network . The business processes such as Supplier Management, Distributor Management, Distribution and Transportation Standard and Qualification, Compliance, including Internal Audit Management, New Product Introduction and Franchise Management, Quality System Oversight on Document management, NC, CAPA, Change Control, Complaints management, Organization and People Qualification and Training.
- Build a shared services strategy that aligns and organizes resources, improves delivery and operational execution, improves business alignment, continuously improves support processes and manages risk and cost of quality.
- Supports the LOCs by providing relevant analytics on the owned processes for the LOCs’ Quality Reviews and identification of improvement opportunities.
- Confers with Management in preparation, formulating and maintaining Business Quality Services organization budget and resources.
Qualifications
- Possess Degree in Science or Engineering disciplines
- Strong technical background, preferably with direct experience in multiple product categories and cultures, with specific quality and regulatory compliance competencies in the areas of quality systems, regulatory affairs & compliance.
- A minimum of 10 years of experience in positions of increasing responsibility. Proven success in strategy development, project management and execution, change management, integrating business needs to quality and regulatory compliance, driving alignment on strategy and approach across multiple differing health authority requirements, building consensus and impacting outcomes.
- Previous experience interfacing with regulatory agencies, e.g., FDA, TGA, notified bodies, etc. and a history of success and credibility employing analytical skills to address complex quality and regulatory compliance requirements.
Primary Location:Asia Pacific-Malaysia-Selangor-Petaling Jaya
Organization: Johnson & Johnson Sdn. Bhd. (8275)
Travel:Yes, 10 % of the Time
Job Function: Quality (Generalist)
Description
The Business Quality Services Head of One SEA Business Quality organization reports solid line to the One SEA Business Quality Senior Director, and connects with each Sectors and Enterprise Quality Systems. The individual is responsible for building and leading a cross-sector Business Quality Services organization for One SEA. The role requires partnership and building of alliances with the SEA Country Business Quality Heads and other stakeholders to execute core Quality Systems and processes for the Local Operating Companies (LOCs).
- Contributes to maintenance, compliance and improvement of the Business Quality Management System in accordance with J&J Enterprise One Quality System and associated Sector standards throughout the SEA organization. Establishes the strategy and accountable for execution of tactical initiatives to comply with local government regulatory requirement on the Quality Systems that it owns.
- Oversees the provision of functional and technical support, training as needed to ensure the integrity of the standards deployment and provide knowledge and insight of emerging trends within the Business Quality Services organization in collaboration with Asia-Pacific.
- Partner with Enterprise and APAC Experts in the development of common Best Practice business processes through the leveraging of the system/process knowledge, experience, internal network . The business processes such as Supplier Management, Distributor Management, Distribution and Transportation Standard and Qualification, Compliance, including Internal Audit Management, New Product Introduction and Franchise Management, Quality System Oversight on Document management, NC, CAPA, Change Control, Complaints management, Organization and People Qualification and Training.
- Build a shared services strategy that aligns and organizes resources, improves delivery and operational execution, improves business alignment, continuously improves support processes and manages risk and cost of quality.
- Supports the LOCs by providing relevant analytics on the owned processes for the LOCs’ Quality Reviews and identification of improvement opportunities.
- Confers with Management in preparation, formulating and maintaining Business Quality Services organization budget and resources.
Qualifications
- Possess Degree in Science or Engineering disciplines
- Strong technical background, preferably with direct experience in multiple product categories and cultures, with specific quality and regulatory compliance competencies in the areas of quality systems, regulatory affairs & compliance.
- A minimum of 10 years of experience in positions of increasing responsibility. Proven success in strategy development, project management and execution, change management, integrating business needs to quality and regulatory compliance, driving alignment on strategy and approach across multiple differing health authority requirements, building consensus and impacting outcomes.
- Previous experience interfacing with regulatory agencies, e.g., FDA, TGA, notified bodies, etc. and a history of success and credibility employing analytical skills to address complex quality and regulatory compliance requirements.
Primary Location:Asia Pacific-Malaysia-Selangor-Petaling Jaya
Organization: Johnson & Johnson Sdn. Bhd. (8275)
Travel:Yes, 10 % of the Time
Job Function: Quality (Generalist)