Senior Quality Systems Leader, GxP & eQMS

Regulatory Jobs; Plymouth Township (PA); Sur place; USD 130 000 - 170 000; Plein temps

Avantages offerts par ce poste

Medical, Vision and Dental benefits

Generous paid time off

401(k) Retirement Savings Plan

Parental leave

Employee Stock Purchase Plan (ESPP)

Résumé du poste

Harmony Biosciences is recruiting for a Senior Manager, Quality Systems to support GxP Quality Systems in our Plymouth Meeting office. You will manage electronic Quality Systems, oversee Quality Events, training programs, and documentation to ensure inspection readiness and continuous improvement across GMP/GLP/GCP domains.

The role partners with operations, Regulatory Affairs and Clinical teams to maintain compliance, manage workflows, and drive quality metrics and CAPA effectiveness.

Qualifications

• Hands-on experience administering electronic Quality Systems (GxP).
• Experience with Veeva Vault QualityDocs, Training, and eQMS modules.
• Experience initiating and managing Quality Events (Change Controls, Deviations, CAPAs).
• Solid understanding of document control, training management, deviations, CAPA, change control, and regulatory readiness.

Responsabilités

• Oversee and maintain electronic Quality Systems (Documentation, Training, Change Control, Deviations, CAPA).
• Provide day-to-day support for Quality Events from initiation to closure.
• Monitor workflows, track due dates, escalate bottlenecks, and drive improvements.
• Draft and review SOPs and other controlled documents to ensure GMP/GLP/GCP alignment.

Connaissances

Quality Systems

GxP Compliance

Veeva Vault

Change Control

CAPA

Document Management

Training Management

Quality Events

Formation

Bachelor’s degree in life sciences / engineering / pharmacy

Outils

Veeva Vault

QualityDocs

eQMS

Description du poste

Harmony Biosciences is recruiting for a Senior Manager, Quality Systems to support GxP Quality Systems in our Plymouth Meeting office. You will manage electronic Quality Systems, oversee Quality Events, training programs, and documentation to ensure inspection readiness and continuous improvement across GMP/GLP/GCP domains.

The role partners with operations, Regulatory Affairs and Clinical teams to maintain compliance, manage workflows, and drive quality metrics and CAPA effectiveness.