Associate Director, Global Complaint Management

Role Overview

• Manage and oversee the global complaint management process, ensuring full QMS lifecycle control.
• Maintain end-to-end oversight of receipt, triage, investigation, documentation, and closure of Product Quality Complaints (PQCs) and Adverse Event (AE) Quality Investigations.
• Execute and support CAPAs and deviations related to the global complaint management process.
• Serve as the QMS SME for complaint management and ensure controlled documents remain current, compliant, and aligned with regulatory expectations.
• Drive alignment with Organon’s QMS across global sites and external business partners and resolve gaps when identified.
• Lead global complaint trending, signal detection, and reporting activities.
• Oversee analysis of PQCs and AE Quality Investigation outcomes to identify trends, recurring issues, and emerging risks.
• Ensure appropriate internal reporting and escalation pathways based on trend outcomes.
• Develop, implement, and optimize AI-based tools to enhance trending accuracy, compliance, and operational efficiency.
• Provide inspection readiness and direct support for regulatory inspections focused on complaint management.
• Respond to inquiries from internal stakeholders, external partners, and health authorities, clearly explaining processes and addressing compliance-related questions.
• Serve as SME for complaint-related IT systems and associated workflows.
• Lead and/or contribute to cross-functional initiatives to enhance complaint systems, business processes, and database applications.
• Identify process and system improvement opportunities and provide recommendations to leadership to ensure compliance and mitigate regulatory/operational risk.
• Analyze issues from multiple perspectives to define problems and drive durable, system-based solutions across the organization.

Requirements

• BS/MS/PhD in Science, Engineering, or related discipline
• Minimum 5 years of experience in the pharmaceutical industry
• Strong preference for experience in Quality, Compliance, and/or Complaint Management
• Ability to manage multiple projects and competing priorities while making balanced, risk-based decisions
• Applies structured, fact-based problem solving grounded in data, science, and regulatory expectations
• Leads with collaboration and inclusivity, working effectively across diverse teams and external partners
• Communicates clearly and influences effectively at all levels of the organization
• Promotes a culture of continuous improvement, identifying opportunities to strengthen processes and reduce risk

Benefits

• retirement savings plan
• paid vacation and holiday time
• paid caregiver/parental and medical leave
• health benefits including medical, prescription drug, dental, and vision coverage