Hybrid Senior Product Complaint Operations Lead

United Therapeutics Corporation; United States; Hybrid; USD 90,000 - 130,000; Full time

Job summary

United Therapeutics Corporation in Durham, NC seeks a Senior Product Complaint Operations Specialist to lead end-to-end product complaint handling for devices, drugs, and biologics. You will drive quality system workflows, training, investigations, and regulatory compliance across global programs.

You will develop training materials, work with cross-functional teams, and ensure timely investigations per ISO 13485, 21 CFR 820, and IMDRF guidelines, while supporting CAPAs and vendor relations.

Qualifications

• Bachelor’s degree in a relevant discipline.
• 5+ years pharmacovigilance in end-to-end case processing or product complaint management.
• 3+ years device/combination product experience.
• Strong knowledge of global regulations and GMP concepts.

Responsibilities

• Manage end-to-end product complaint handling and related quality system workflows.
• Develop and deliver training on product complaint handling per SOPs and regulations.
• Provide QA support for vendor and product complaint workflows and investigations.
• Stay current on global regulations, guidelines and industry best practices.
• Coordinate product complaint and returns processes and collaborate with QA to close PCs.
• Interface with patients, pharmacists, and physicians for complaint information.

Skills

Pharmacovigilance

Case processing

Product complaints

GMP

ISO 13485

IMDRF

MedDRA

Argus

Project management

Regulatory knowledge

Education

Bachelor’s degree

Master’s degree

Tools

Argus

Job description

United Therapeutics Corporation in Durham, NC seeks a Senior Product Complaint Operations Specialist to lead end-to-end product complaint handling for devices, drugs, and biologics. You will drive quality system workflows, training, investigations, and regulatory compliance across global programs.

You will develop training materials, work with cross-functional teams, and ensure timely investigations per ISO 13485, 21 CFR 820, and IMDRF guidelines, while supporting CAPAs and vendor relations.