MSBH Quality Management System (QMS) Senior Manager
Must-have:AISeniorLead
Key Responsibilities
- QMS Strategy, Governance & Compliance
- Define and lead the site QMS strategy, priorities, and improvement roadmap.
- Ensure alignment with corporate, global, regulatory, and customer requirements.
- Oversee QMS processes, including document control, change management, training, risk management, and process governance.
- Drive standardization and effective deployment of QMS requirements across functions.
- Advise site leadership on QMS performance, compliance risks, and improvement priorities.
- Audit Leadership
- Lead the strategy and readiness for internal, external, certification, corporate, and customer audits.
- Oversee audit planning, auditor capability, evidence quality, audit responses, and closure of findings.
- Represent the organization during significant audits and management discussions.
- Drive systemic improvement based on audit trends and lessons learned.
- Promote a zero non-conformance mindset and sustained audit readiness.
- Non-Conformance & CAPA Management
- Provide governance for non-conformance, root cause analysis, corrective action, and effectiveness verification.
- Ensure significant and recurring issues are properly escalated, investigated, and resolved.
- Drive systemic corrective actions to prevent recurrence across processes and functions.
- Performance Monitoring & Management Review
- Define and monitor QMS KPIs, including audit performance, CAPA effectiveness, process compliance, and system health.
- Lead management reviews and business process reviews using the PDCA approach.
- Provide data-driven insights, dashboards, and recommendations to senior leadership.
- Ensure actions and decisions from management reviews are effectively followed through.
- Continuous Improvement & Digital Transformation
- Lead quality-system improvement initiatives and cross-functional transformation projects.
- Drive digitalization, automation, analytics, and AI solutions to improve QMS efficiency and visibility.
- Simplify and standardize processes while maintaining effective controls and compliance.
- Promote a culture of continuous improvement and operational excellence.
- Risk Management
- Lead QMS risk identification, assessment, mitigation, monitoring, and escalation.
- Ensure alignment with enterprise risk-management and business continuity frameworks.
- Oversee quality risks related to changes, suppliers, new products, technologies, and operations.
- Communicate significant risks and mitigation status to leadership.
- Stakeholder & Cross-Functional Alignment
- Partner with manufacturing, engineering, operations, quality, and support functions.
- Align site practices with global QMS standards and strategic priorities.
- Engage customers, auditors, certification bodies, suppliers, and other external stakeholders when required.
- Influence leadership and stakeholders on quality strategies, priorities, and risk-based decisions.
- People Leadership & Capability Development
- Lead, coach, and develop QMS managers, engineers, specialists, auditors, and process owners.
- Build QMS capability, succession plans, and a sustainable talent pipeline.
- Ensure QMS training and competency requirements are defined and fulfilled.
- Promote accountability, collaboration, inclusion, and quality ownership across the organization.
Qualifications & Requirements
- Bachelor’s or Master’s degree in Engineering, Science, Quality, Manufacturing, or a related field.
- Typically 12 or more years of experience in Quality, QMS, Engineering, or Manufacturing, including leadership experience.
- Strong knowledge of ISO 9001, IATF 16949, audit processes, CAPA, risk management, and management review.
- Proven experience leading major audits, QMS governance, and cross-functional improvement programs.
- Strong strategic thinking, analytical, problem-solving, and decision-making skills.
- Proven people leadership, coaching, stakeholder management, and influencing capabilities.
- Excellent communication and ability to engage senior leadership, customers, and global teams.
- Artificial Intelligence (AI) proficiency is required.