Senior Specialist, Global Complaint Management

Organon • Lower Gwynedd Township, PA

22d • Onsite

About The Position

The Senior Specialist, Global Complaint Management plays a key role in the execution of Organon’s global product quality complaint process. This position is responsible for processing complaint handling records, ensuring they are accurately documented and advanced to the appropriate sites or functions for investigation. The role also manages day‑to‑day operations of the complaint sample laboratory, including receipt and logging of complaint samples, oversight of sample evaluations, and coordination of shipments to investigation sites to ensure timely and compliant analysis. In addition, the Senior Specialist is responsible for global complaint and customer feedback trending activities utilizing statistical process controls while ensuring data accuracy and completeness to enable reliable signal detection and quality reporting. The role executes complaint procedures in accordance with global regulatory requirements and collaborates closely with Organon manufacturing sites and functional partners to support consistent, compliant complaint-handling practices. The position contributes to process improvements, helping to strengthen performance, efficiency, and compliance within the global complaint management network. The role is set to be in our Laboratory located in Spring House Innovation Park (SHIP) site located at 727 Norristown Road; Building 4; Lower Gwynedd, PA 19002, 2 to 3 days a week.

Requirements

• BS in Science Field, Engineering Field or a related relevant discipline.
• Minimum of three plus years' experience within the pharmaceutical industry.
• Strong statistical expertise and previous quality/compliance experience required.
• Requires established ability to manage time with competing priorities.
• Requires ability to identify and implement continuous improvement principles.
• Excellent problem-solving skills, based on science, facts, data and understanding of regulatory requirements.
• Ability to persuade others to solve straightforward problems.
• Strong demonstrated interpersonal, communication, collaboration and leadership skills; and ability to work in a diverse environment.

Nice To Haves

• Previous complaint experience preferred.

Responsibilities

• Compile, analyze, and interpret global complaint data, applying statistical process control (SPC) and other analytical tools to support trending, signal detection, and quality reporting.
• Manage day‑to‑day operations of the complaint sample laboratory, including sample receipt, logging, evaluation coordination, and shipment of samples to investigation sites.
• Site based role three to four days per week.
• Process product quality complaint records and advance them to the appropriate sites/functions for investigation.
• Ensure accurate and timely entry of complaint data in the electronic complaint system and provide system user support.
• Support development and maintenance of SOPs and QMS documents related to complaint handling and system usage.
• Prepare complaint data and system information for regulatory inspections.
• Partner with IT on complaint system enhancements, issue resolution, and user access, as needed.
• Participate in continuous improvement initiatives to strengthen the effectiveness, consistency, and compliance of global complaint‑handling processes.

Benefits

• Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level