Senior Quality Systems Lead – GxP & eQMS Excellence

Harmony Biosciences; Harmonville (PA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical, Vision & Dental

Paid time off

Disability & Life Insurance

401(k) Plan

Parental leave

ESPP

Wellness programs

Professional development

Great Place to Work

Job summary

Harmony Biosciences is seeking a Senior Manager, Quality Systems to support GxP quality systems in the Plymouth Meeting office. You will administer Quality Events, document control, training processes, SOP revisions, and Quality metrics to ensure inspection-ready systems and continuous improvement across GMP/GLP/GCP domains.

The role requires hands-on experience with electronic quality systems (preferably Veeva Vault), change controls, deviations, CAPAs, and training management, plus strong

Qualifications

• Bachelor's degree in life sciences, engineering, pharmacy, or related discipline
• 7+ years GMP Quality Assurance, Quality Systems, or manufacturing quality in pharmaceutical/biotech
• Hands-on experience administering or supporting electronic Quality Systems (preferably Veeva Vault QualityDocs/Training/eQMS)
• Experience initiating, reviewing, and managing Quality Events (Change Controls, Deviations, CAPAs, CI records)
• Strong understanding of quality system processes: document control, training, deviations, CAPA, change control, risk management, investigations, inspection readiness
• Technical writing and document management skills with SOPs, work instructions, forms
• Strong computer, organizational, and analytical abilities
• Excellent verbal and written communication across stakeholders

Responsibilities

• Maintain electronic Quality Systems (Document Management, Training, Change Control, Deviations, CAPA)
• Provide day-to-day support for Quality Events from initiation through closure
• Monitor Quality Event workflows, aging, and due dates; escalate bottlenecks and improve processes
• Draft, revise, and review SOPs, work instructions, forms, and controlled documents
• Ensure harmonization across GMP/GLP/GCP and regulatory standards
• Troubleshoot Veeva Vault and other GxP systems; coordinate issue resolution and user support
• Administer GxP training program and related processes (Veeva Vault Training, curricula)
• Ensure systems meet regulatory requirements and business needs
• Oversee document lifecycle activities in Veeva Vault QualityDocs
• Develop Quality System metrics and trends; prepare Quality Management Review materials
• Collaborate with process owners to ensure procedural compliance and proper eQMS use
• Provide oversight for additional GxP-regulated systems; perform other duties as assigned

Education

Bachelor's degree in life sciences, engineering, pharmacy, or related discipline

7+ years GMP Quality Assurance/Quality Systems experience

Experience administering electronic Quality Systems (Veeva Vault)

Quality events management (Change Controls, Deviations, CAPAs)

Strong written and verbal communication

Tools

Veeva Vault QualityDocs

Veeva Vault Training

eQMS modules

Job description

Harmony Biosciences is seeking a Senior Manager, Quality Systems to support GxP quality systems in the Plymouth Meeting office. You will administer Quality Events, document control, training processes, SOP revisions, and Quality metrics to ensure inspection-ready systems and continuous improvement across GMP/GLP/GCP domains.

The role requires hands-on experience with electronic quality systems (preferably Veeva Vault), change controls, deviations, CAPAs, and training management, plus strong