Quality Engineering Manager - GMP & Compliance

RXinsider LTD.; Petersburg (VA); On-site; USD 150,000 - 190,000; Full time

Job summary

RXinsider LTD. is seeking a Quality Leader responsible for independent oversight and governance of engineering, manufacturing, and technical support to ensure cGMP compliance and high-quality outputs.

The role maintains the QMS, ensures inspection readiness, and reviews QMS records, investigations, protocols, technical reports, and system deliverables to support sterile injectable and combination products.

Qualifications

• Bachelor’s degree in a scientific discipline and minimum 10 years of Quality/cGMP experience.
• Knowledge translating FDA/EMA requirements into operational success (e.g., Annex 1, 21 CFR Part 11).
• Technical experience in sterile injectable medications, combination products, and medical devices is desirable.
• Experience leading regulatory inspections (FDA/EMA) and ensuring inspection readiness.

Responsibilities

• Provide leadership and support to Quality Engineering and other departments to ensure qualified personnel and safe operations.
• Establish and maintain GMP-compliant quality system processes across facility, equipment, and manufacturing.
• Review and approve documentation supporting product and device-related activities for regulatory compliance.
• Lead investigations, deviations, CAPAs, and change controls with risk-based decisions.

Skills

Quality management

cGMP

Regulatory knowledge

Investigation leadership

Project management

FDA/EMA inspections

Education

Bachelor’s degree in a scientific discipline

Tools

CMMS

Job description

RXinsider LTD. is seeking a Quality Leader responsible for independent oversight and governance of engineering, manufacturing, and technical support to ensure cGMP compliance and high-quality outputs.

The role maintains the QMS, ensures inspection readiness, and reviews QMS records, investigations, protocols, technical reports, and system deliverables to support sterile injectable and combination products.