Associate Director, Global Complaint Management
Organon
full-time
Posted on:
Location Type: Hybrid
Location: Lower Gwynedd Township • New Jersey • Pennsylvania • United States
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Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
QMS lifecycle controlCAPAscomplaint managementsignal detectiontrend analysisAI-based toolsregulatory compliancedata analysisproblem solvingprocess improvement
Soft Skills
project managementrisk-based decision makingcollaborationinclusivitycommunicationinfluencingcontinuous improvementleadershipcross-functional teamworkstakeholder engagement