QMS Manager Full Time

The QMS Manager is responsible for maintaining, enhancing, and harmonizing the Quality Management System across regional and global operations while serving as the primary Quality lead for an enterprise-wide ERP transformation program. This role partners closely with cross functional teams—including IT, Supply Chain, Manufacturing, Engineering, Regulatory, and Quality—to ensure that all QMS processes, documentation, and data structures integrate seamlessly into the new ERP platform. The individual ensures compliance with applicable regulatory standards, drives continuous improvement, and effectively manages change to existing QMS processes.

PRIMARY DUTIES AND RESPONSIBILITIES

PRIMARY DUTIES AND RESPONSIBILITIES* (List of 8 – 10 key tasks required of the job which are essential to the performance of this job. LIMIT OF 4,000 CHARACTERS)

ERP Project Support (Primary Responsibility)

• Serve as the Quality Management Process Owner within the ERP project, ensuring that quality processes (e.g., nonconformances, CAPA, audits, change control, document control) are accurately mapped, validated, and integrated.
• Translate QMS requirements into ERP functional specifications; collaborate with IT and process teams to design compliant workflows.
• Lead or support User Requirement Specifications (URS), design reviews, validation protocols, and UAT related to Quality modules.
• Ensure ERP configuration aligns with global QMS policies, regulatory requirements, and industry standards.
• Identify and mitigate quality related risks tied to system migration, master data, document migration, and process harmonization.
• Support global training development for Quality modules and deliver training as required.

Global & Regional QMS Governance

• 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.
• Lead harmonization of legacy or site-specific processes into a standardized global model.
• Ensure regional sites adopt and sustain updated QMS processes and tools.
• Monitor compliance readiness and partner with sites to close gaps identified during audits or process reviews.

Compliance and Regulatory Alignment

• Ensure QMS processes comply with ISO 9001, ISO 13485 (if applicable), FDA 21 CFR Parts 820/11, and other regional requirements.
• Support internal and external audits by acting as subject matter expert on process and system changes.
• Ensure ERP-related process changes are appropriately validated and documented per GxP/GMP requirements.

Continuous Improvement

• Identify improvement opportunities within current QMS processes and help deploy scalable, standardized solutions.
• Use data analytics from ERP and QMS tools to monitor performance, trends, and compliance metrics.
• Promote a culture of quality and process excellence across the organization.

Stakeholder Engagement

• Collaborate with global, regional, and site-level Quality Leaders to align priorities and rollout plans.
• Provide regular updates to senior leadership on implementation progress, risks, and mitigation strategies.
• Facilitate cross-functional workshops and working sessions to drive consensus.

MINIMUM QUALIFICATIONS

• Bachelor’s degree in engineering, life sciences, Quality, or related field.
• 5–10+ years of experience in Quality Management Systems within manufacturing, medical devices, pharmaceuticals, biotech, industrials, or similar regulated environments.
• Strong knowledge of QMS processes (CAPA, NCR, audits, document control, change control, training, complaints).
• Experience supporting or leading ERP Quality modules (SAP, Oracle, Microsoft Dynamics, Infor, etc.).
• Demonstrated experience with regulated system validation (CSV / GxP / Part 11).
• Business-level proficiency in Japanese is mandatory, as this role requires frequent interaction with Japan-based stakeholders.
• Ability to work in global working hours, heavy in JST time zone