QMS Manager

Mô tả Công việc
This position will report to Quality Management - Global Senior Manager and be responsible for developing, implementing, and continuously improving the company's Quality Management System (QMS), ensuring alignment across sites, functions, customer requirements, regulatory standards, and corporate governance expectations. The role serves as the process owner for quality governance, internal audit programs, CAPA effectiveness, quality standards deployment, and QMS maturity enhancement.
This is a hands-on individual contributor role in the initial phase of the Quality Management transformation. The incumbent is expected to independently develop and implement quality management processes, documentation, audit programs, governance mechanisms, and training materials while working closely with cross-functional stakeholders.
**Key Responsibilities:**
1. QMS Governance, Standardization & Documentation
Develop, maintain, and continuously improve Quality Policies, Procedures, SOPs, Work Instructions, and quality records, ensuring effective document control and governance.
Establish and govern the framework for Product Quality Standards and Quality Control requirements across all sites.
Drive standardization and harmonization of quality management processes to ensure compliance with ISO 9001, customer requirements, regulatory requirements, and internal governance standards.
Lead QMS enhancement initiatives to improve process effectiveness, consistency, and operational efficiency.
2. Training, Competency & Quality Culture
Develop and implement QMS training, competency assessment, and capability-building programs to promote a strong quality culture and enhance organizational quality maturity across functions and sites.
3. Audit, CAPA, Continuous Improvement
Develop and manage the internal quality audit framework, including audit planning, methodologies, scoring mechanisms, and execution.
Monitor and verify the timely and effective closure of audit findings, non-conformities (NCs), Areas for Improvement (AFIs), and CAPA actions.
Govern CAPA, RCA, and continuous improvement processes to ensure sustainable resolution of quality issues.
Analyze audit and quality performance data to identify systemic risks, trends, and improvement opportunities, while facilitating cross-functional problem-solving initiatives.
4. Quality Governance & Performance Management
Coordinate and facilitate monthly Quality Governance Review meetings, including preparation of quality performance reports, audit results, CAPA updates, risk assessments, and action tracking.
Develop, maintain, and report QMS-related KPIs and governance metrics to support management review and decision-making.
Consolidate quality performance data, identify significant risks or systemic issues, and support management reporting and escalation processes.
5. Digital Quality & System Enhancement
Support the digitalization of quality management processes and collaborate with IT and business stakeholders on system enhancement initiatives.
Promote data-driven decision-making through effective use of quality analytics and reporting tools.