Resilience

Product Manager

• Own the product complaints program, ensuring timely evaluation, investigation, and closure of product quality complaints
• Set complaint intake, triage, categorization, criticality criteria, and turnaround expectations
• Set investigation standards and approve conclusions on root cause, product impact, reportability, and CAPA initiation
• Lead escalated, precedent-setting, or client-sensitive complaint cases
• Ensure complaint handling complies with GMP, regulatory, company procedure, and Quality Agreement requirements
• Prepare and present quarterly and annual complaint trend reports to site and global quality leadership
• Serve as authoritative voice on complaint findings and outcomes to clients and regulatory agencies
• Design and implement complaint-handling process improvements
• Lead cross-functional teams across quality assurance, manufacturing, quality control, and client functions
• Ensure complaint documentation is accurate, complete, and maintained; review and approve investigations, forms, SOPs, and work instructions
• Define complaint-handling KPIs and performance targets, set team goals, and act on adverse trends
• Represent the Product Complaints Program as subject-matter expert during FDA, regulatory, and client audits and inspections
• Own complaint-related inspection readiness, document availability, inspection-room support, and staff preparation
• Partner with operational and client-facing teams to secure resources and commitments for timely complaint closure
• Set annual improvement goals and workstream priorities for the complaints program
• Influence and educate operational and support areas on quality and compliance expectations
• Lead, coach, and develop direct reports through goal setting, performance reviews, feedback, recognition, training, and qualification
• Serve as site point of contact for the Product Complaints Program
• Escalate site-specific complaint issues with recommended containment and corrective actions
• Determine staffing, systems, and budget needs; negotiate timelines and resources with peer functional leaders

Senior Manager, Product Complaints