GxP Quality & Compliance Auditor + SOP Writer

ProPharma Group; United States; Hybrid; USD 110,000 - 150,000; Full time

Job summary

ProPharma Group is hiring a Compliance and Quality Assurance Consultant (CQA) to support GMP/GxP compliance projects, QMS development, audits, and regulatory actions across client programs. The role involves consulting, CAPA implementation, and training, with travel as needed.

The ideal candidate brings 5+ years in QA/regulatory fields, strong knowledge of CFRs and EU GMP/GDP, and excellent client-facing communication. Hybrid work options offered.

Qualifications

• Knowledge of US FDA, ICH, EMA, MHRA regulations and guidance documents.
• Expertise in GxP systems and capable of providing consultation based on experience.
• Strong ability to plan, organize, control and execute projects with client confidence.

Responsibilities

• Represent the company in assigned areas of quality assurance and regulatory/GxP.
• Provide consultative support for CQA projects and QMS development.
• Lead audits and QA oversight, and respond to regulatory actions as needed.
• Promote continual improvement and CAPA implementation across client programs.
• Coordinate training and knowledge transfer to clients and internal teams.
• Travel as required and engage with clients at multiple levels to ensure compliance.

Skills

FDA regulations

GxP expertise

Auditing

Communication

Education

Bachelor’s degree in a scientific discipline

MSc/PhD in a scientific discipline

Job description

ProPharma Group is hiring a Compliance and Quality Assurance Consultant (CQA) to support GMP/GxP compliance projects, QMS development, audits, and regulatory actions across client programs. The role involves consulting, CAPA implementation, and training, with travel as needed.

The ideal candidate brings 5+ years in QA/regulatory fields, strong knowledge of CFRs and EU GMP/GDP, and excellent client-facing communication. Hybrid work options offered.