Associate Director, Global Complaint Management

Location: Gwynedd Valley

This job is with Organon, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Job Description
The Position
The Associate Director of Global Complaint Management serves as a global subject matter expert responsible for shaping, executing, and continuously improving Organon's Quality Management System (QMS) for product quality complaint management across biologics, pharmaceuticals, and combination medical device products. This role leads the development and enhancement of global complaint management processes, including governance of complaint IT systems and creation of a robust global trending and signal detection platform to monitor, analyze, and report complaint data.

The Associate Director provides strategic guidance to ensure complaint processes-including intake, evaluation, adverse event linkage, and global reporting-meet worldwide regulatory expectations and evolving industry standards. The position partners closely with complaint intake teams, Global Safety, Global Security, and other quality functions. Expertise in AI-enabled analytics, Power BI, and statistical process control is essential to drive innovation, improve data accuracy, and strengthen overall compliance.
Responsibilities  
· 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.
Required Education, Experience and Skills  
· 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.
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Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the…