Senior Manager, GxP Quality Systems & Compliance

Harmony Biosciences; Philadelphia (Philadelphia County); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Medical benefits

Vision & Dental benefits

PTO and Holidays

Disability & Life Insurance

401(k) Retirement Savings Plan

Parental leave

ESPP

Wellness programs

Professional development

Job summary

Harmony Biosciences is seeking a Senior Manager, Quality Systems to join our Plymouth Meeting, PA office. You will oversee day-to-day operation of GxP Quality Systems, ensuring compliance with ICH/FDA and inspection readiness across documents, training, and CAPA processes.

You will partner with Process Owners and cross-functional teams to optimize workflows, manage Veeva Vault QualityDocs and related eQMS modules, and drive continuous improvement in quality metrics and regulatory readiness.

Qualifications

• Bachelor's degree in life sciences, engineering, pharmacy, or related discipline.
• 7+ years in GMP QA, Quality Systems, or manufacturing quality in pharma/biotech.
• Experience with electronic Quality Systems (Veeva Vault) preferred.

Responsibilities

• Manage electronic Quality Systems (Document Management, Training, Change Control, Deviations, CAPA).
• Support Quality Events from initiation to closure and continuous improvement.
• Monitor workflows, escalate bottlenecks, and improve processes.
• Draft and review SOPs, work instructions, and controlled documents.
• Ensure GxP harmonization across GMP/GLP/GCP and regulatory alignment.
• Provide support for Veeva Vault QA systems and issue resolution.
• Administer training programs and maintain inspection-ready records.
• Generate Quality System metrics and present to Quality Mgmt Review.
• Collaborate with cross-functional stakeholders to ensure compliance.

Skills

Quality Systems

GxP Compliance

Quality Assurance

Regulatory Compliance

Document Management

CAPA

Training Management

Change Control

Communication

Education

Bachelor's degree in life sciences/engineering/pharmacy

Tools

Veeva Vault

QualityDocs

eQMS modules

Job description

Harmony Biosciences is seeking a Senior Manager, Quality Systems to join our Plymouth Meeting, PA office. You will oversee day-to-day operation of GxP Quality Systems, ensuring compliance with ICH/FDA and inspection readiness across documents, training, and CAPA processes.

You will partner with Process Owners and cross-functional teams to optimize workflows, manage Veeva Vault QualityDocs and related eQMS modules, and drive continuous improvement in quality metrics and regulatory readiness.