Cluster Quality Senior Manager

Position Summary
The Cluster Quality Senior Manager is accountable for leading and sustaining quality systems, regulatory compliance, and overseeing site quality performance across the defined manufacturing and supply chain cluster.
This role provides direct quality leadership and technical support to multiple manufacturing sites, ensuring consistent application of corporate Quality Management System (QMS) requirements, compliance with applicable regulations, and effective risk management throughout the product lifecycle.
The position acts as the primary quality authority for the cluster, supporting operational excellence while enabling reliable speed to market and ensuring delivery of right‐first‐time, compliant products.
The role reports to the Segment Quality Director and operates as a senior leader within the cluster Quality organization.
Key Customers and Stakeholders
• Cluster Operations and Supply Chain leadership
• Plant Managers and Site Leadership Teams
• Manufacturing and Engineering teams
• Research & Engineering (R&E)
• Global Quality, Regulatory and compliance functions such as QMS, SQM, Regulatory Affairs and Product Safety
• Sales, Marketing, and Customer Service
• Corporate functions (Legal, Finance, HR as applicable)
• External partners, suppliers, and regulatory authorities (as required)
Scope of Responsibility
Oversight of multiple manufacturing sites (including ECMs) within the assigned cluster Quality and compliance responsibility for:
• Manufacturing operations
• Supply chain and suppliers
• Product release
• Complaints, and post‐market surveillance
• Direct involvement in audits, inspections, and regulatory interactions
• Strong interface with regional and corporate Quality, Regulatory, and technical teams
• Acts as escalation point for complex quality and compliance issues
Essential Accountabilities
• Site Quality Leadership & Oversight
o Provide direct supervision and governance of quality performance across assigned sites (including ECM).
o Ensure all locations maintain a state of continuous inspection readiness.
o Lead and participate in internal, external, and regulatory audits.
o Drive effective closure of audit findings, deviations, and CAPAs.
o Support Plant Managers in strengthening quality culture and accountability.
o Technical Quality Support to Operations
• Serve as the senior quality technical expert for the cluster.
o Support manufacturing and supply chain teams in:
o Root cause investigations and complex problem solving
o Nonconformance management and deviation handling
o Change control, product release, and risk assessments
o Act as escalation point for critical quality, safety, and compliance decisions.
• Quality Management System (QMS) Governance
o Ensure effective deployment and sustained compliance of corporate QMS processes.
o Identify system gaps and lead corrective and preventive actions.
o Facilitate and support Management Review processes at site and cluster level.
o Champion standardization and consistent execution across sites.
• Regulatory Compliance & Advisory
o Maintain active oversight of applicable regulatory requirements for the cluster (e.g., medical devices, cosmetics, consumer goods, as applicable).
o Provide guidance and advisory support to operations and business partners on regulatory expectations and risks.
o Support regulatory inspections and interactions with agencies (e.g. FDA, EU, BIS, ANVISA, INVIMA, other applicable).
o Monitor regulatory changes and assess potential business impact.
• Continuous Improvement & Capability Building
o Sponsor and lead quality‐driven continuous improvement initiatives.
o Strengthen quality capabilities at site and cluster level through coaching, training, and mentoring.
o Share best practices across sites and contribute to regional quality learning.
• Collaboration & Influence
o Act as a strong business partner, balancing compliance, risk management, and operational efficiency.
o Influence across functional and geographic boundaries within a matrix organization.
o Represent cluster quality priorities to regional Quality leadership.