Senior Quality Systems Leader (GxP/eQMS)

ADP, Inc.; Harmonville (PA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical, Vision, and Dental benefits

Generous paid time off and holidays

401(k) retirement plan

Parental leave

Job summary

Harmony Biosciences is seeking a Senior Manager, Quality Systems to lead day-to-day operation and continuous improvement of electronic GxP systems from Quality Events to training and documentation. You’ll collaborate with Regulatory, Clinical and Medical Affairs to ensure inspection readiness and regulatory compliance.

The role emphasizes administration of Veeva Vault QualityDocs, CAPAs, deviations, and change control, with a strong focus on metrics, training and cross‑functional alignment.

Qualifications

• Bachelor’s degree in life sciences, engineering, pharmacy, or a related discipline required; advanced degree preferred.
• 7+ years within GMP Quality Assurance, Quality Systems, technical operations quality, or manufacturing quality in pharma/biotech.
• Hands‑on experience administering/supporting electronic Quality Systems, preferably Veeva Vault QualityDocs, Training, eQMS modules.
• Experience initiating, reviewing, managing Quality Events in an electronic QMS (Change Controls, Deviations, CAPAs, CI).
• Strong understanding of quality system processes: document control, training management, deviations, CAPA, change control, risk management, investigations, inspection readiness.
• Technical writing and document-management skills; authoring/revising SOPs and controlled documents.
• Strong computer, organizational, and analytical skills; excellent written and verbal communication.

Responsibilities

• Manage and maintain electronic Quality Systems (Document Management, Training, Change Control, Deviations, CAPA).
• Provide day-to-day support for Quality Events from initiation through closure.
• Monitor workflows, track quality metrics, and escalate bottlenecks for improvements.
• Draft and review SOPs, work instructions, forms, and other controlled documents.
• Ensure harmonization across GMP/GLP/GCP domains and regulatory alignment.
• Troubleshoot GxP system issues (Veeva Vault) and support workflow improvements.
• Administer training programs and maintain inspection-ready records.
• Produce metrics and reports for Quality Management Review.

Skills

Verbal communication

Written communication

Analytical skills

Organizational skills

Computer skills

Education

Bachelor’s degree in life sciences/engineering/pharmacy

Advanced degree preferred

Tools

Veeva Vault (QualityDocs, Training, eQMS)

Job description

Harmony Biosciences is seeking a Senior Manager, Quality Systems to lead day-to-day operation and continuous improvement of electronic GxP systems from Quality Events to training and documentation. You’ll collaborate with Regulatory, Clinical and Medical Affairs to ensure inspection readiness and regulatory compliance.

The role emphasizes administration of Veeva Vault QualityDocs, CAPAs, deviations, and change control, with a strong focus on metrics, training and cross‑functional alignment.