Senior Quality Systems Leader

US WorldMeds, LLC; Philadelphia (Philadelphia County); On-site; USD 110,000 - 140,000; Full time

Job summary

US WorldMeds, LLC in Philadelphia, PA seeks a Manager, Quality Systems to lead the development, implementation, and maintenance of company-wide quality systems ensuring GxP compliance.

This on-site, Mon-Fri role oversees CAPA, change control, deviations/investigations, document management, internal audits, and regulatory inspections, with oversight of training, metrics, and management reviews to support product quality and regulatory submissions.

Qualifications

• Bachelor’s Degree required.
• Minimum eight years experience in the pharmaceutical, medical device, vaccines, blood, or biologics industry.
• Minimum 5 years experience in quality assurance with quality systems responsibilities.

Responsibilities

• Lead development, implementation, and continuous improvement of all quality systems.
• Maintain document management systems for GxP docs; liaise with third parties as needed.
• Establish training programs and ensure regulatory quality system understanding across the organization.
• Coordinate Management Review Meetings; collect and present quality metrics monthly.
• Manage deviation, investigation, and product quality complaint programs.
• Oversee change control and CAPA processes; monitor performance and progress.

Skills

Quality systems leadership

Auditing

Change control

CAPA

Deviations / Investigations

Document management

Training administration

Regulatory inspections

GxP compliance

Project management

Education

Bachelor’s Degree

Job description

US WorldMeds, LLC in Philadelphia, PA seeks a Manager, Quality Systems to lead the development, implementation, and maintenance of company-wide quality systems ensuring GxP compliance.

This on-site, Mon-Fri role oversees CAPA, change control, deviations/investigations, document management, internal audits, and regulatory inspections, with oversight of training, metrics, and management reviews to support product quality and regulatory submissions.