QMS Manager

Role Overview:

You will be responsible for maintaining, enhancing, and harmonizing the Quality Management System across regional and global operations. As the primary Quality lead for an enterprise-wide ERP transformation program, you will partner closely with cross-functional teams to ensure seamless integration of QMS processes into the new ERP platform. Your role will involve ensuring compliance with regulatory standards, driving continuous improvement, and managing changes to existing QMS processes effectively.

Key Responsibilities:

• Serve as the Quality Management Process Owner within the ERP project, ensuring accurate mapping, validation, and integration of quality processes such as nonconformances, CAPA, audits, change control, and document control.
• Translate QMS requirements into ERP functional specifications, collaborate with IT and process teams to design compliant workflows, and lead or support User Requirement Specifications, design reviews, validation protocols, and UAT related to Quality modules.
• Maintain and improve global QMS processes, procedures, and documentation, act as a change owner or reviewer for QMS process updates triggered by ERP transformation or business needs, and lead harmonization of legacy or site-specific processes into a standardized global model.
• Ensure QMS processes comply with ISO 9001, ISO 13485, FDA 21 CFR Parts 820/11, and other regional requirements, support internal and external audits, and ensure ERP-related process changes are appropriately validated and documented per GxP/GMP requirements.
• Identify improvement opportunities within current QMS processes, deploy scalable, standardized solutions, use data analytics to monitor performance, trends, and compliance metrics, and promote a culture of quality and process excellence across the organization.
• Collaborate with global, regional, and site-level Quality Leaders, provide regular updates to senior leadership, and facilitate cross-functional workshops and working sessions to drive consensus.

Qualifications Required:

• Bachelors degree in engineering, life sciences, Quality, or a related field.
• 510+ years of experience in Quality Management Systems within regulated environments.
• Strong knowledge of QMS processes such as CAPA, NCR, audits, document control, change control, and training.
• Experience supporting or leading ERP Quality modules.
• Demonstrated experience with regulated system validation.
• Business-level proficiency in Japanese is mandatory.
• Ability to work in global working hours, heavy in JST time zone. Role Overview:

You will be responsible for maintaining, enhancing, and harmonizing the Quality Management System across regional and global operations. As the primary Quality lead for an enterprise-wide ERP transformation program, you will partner closely with cross-functional teams to ensure seamless integration of QMS processes into the new ERP platform. Your role will involve ensuring compliance with regulatory standards, driving continuous improvement, and managing changes to existing QMS processes effectively.

Key Responsibilities:

• Serve as the Quality Management Process Owner within the ERP project, ensuring accurate mapping, validation, and integration of quality processes such as nonconformances, CAPA, audits, change control, and document control.
• Translate QMS requirements into ERP functional specifications, collaborate with IT and process teams to design compliant workflows, and lead or support User Requirement Specifications, design reviews, validation protocols, and UAT related to Quality modules.
• Maintain and improve global QMS processes, procedures, and documentation, act as a change owner or reviewer for QMS process updates triggered by ERP transformation or business needs, and lead harmonization of legacy or site-specific processes into a standardized global model.
• Ensure QMS processes comply with ISO 9001, ISO 13485, FDA 21 CFR Parts 820/11, and other regional requirements, support internal and external audits, and ensure ERP-related process changes are appropriately validated and documented per GxP/GMP requirements.
• Identify improvement opportunities within current QMS processes, deploy scalable, standardized solutions, use data analytics to monitor performance, trends, and compliance metrics, and promote a culture of quality and process excellence across the organization.
• Collaborate with global, regional, and site-level Quality Leaders, provide regular updates to senior leadership, and facilitate cross-functional workshops and working sessions to drive consensus.

Qualifications Required:

• Bachelors degree in engineering, life sciences, Quality, or a related field.
• 510+ years of experience in Quality Management Systems within regulated environments.
• Strong knowledge of QMS processes such as CAPA, NCR, audits, document control, change control, and training.
• Experience supporting or leading ERP Quality modules.
• Demonstrated experience with r