Remote GxP Compliance Auditor & SOP Writer — QA Expert

ProPharma Group; Raleigh (NC); Hybrid; USD 110,000 - 160,000; Full time

Job summary

ProPharma Group is seeking a Compliance and Quality Assurance Consultant (CQA) to support QA and GxP compliance projects and provide regulatory consulting to clients. The role covers QMS development, QA oversight, and auditing, with potential work across GMP, GLP, and GCP areas.

The consultant will maintain knowledge of evolving regulatory requirements, contribute to CAPAs, and may engage in client training and cross-functional collaboration. Travel to client sites is expected.

Qualifications

• Bachelor's degree in a scientific discipline required.
• Graduate degree (MSc/PhD) preferred.
• Eligible to be registered as QP, RP, and RPi.
• Minimum 5 years relevant QA/GxP experience.

Responsibilities

• Represent the company in QA and GxP areas.
• Support management of CQA projects and client consulting.
• Lead audits and development of Quality Management Systems (QMS).
• Stay current with FDA/ICH/EU GMP guidance.
• Travel as required and operate in a compliant, risk-based manner.

Skills

FDA regulations

GxP knowledge

Regulatory consulting

Travel willingness

English communication

Education

Bachelor's degree in science

MSc/PhD preferred

QP/RP/RPi eligibility

Tools

QMS development

Job description

ProPharma Group is seeking a Compliance and Quality Assurance Consultant (CQA) to support QA and GxP compliance projects and provide regulatory consulting to clients. The role covers QMS development, QA oversight, and auditing, with potential work across GMP, GLP, and GCP areas.

The consultant will maintain knowledge of evolving regulatory requirements, contribute to CAPAs, and may engage in client training and cross-functional collaboration. Travel to client sites is expected.