GxP Compliance Architect, QA Auditor & SOP Writer

propharmagroup; United States; On-site; USD 100,000 - 160,000; Full time

Job summary

ProPharma Group in the United States seeks a Compliance and Quality Assurance Consultant (CQA) to support GxP compliance projects across GMP, GCP, and GLP domains. You will provide expert consultation, lead audits, and help develop and maintain quality management systems.

Travel may be required; strong knowledge of US FDA, ICH, EMA guidance; ability to mentor clients and coordinate with cross-functional teams; proficiency in English and another European language preferred.

Qualifications

• Knowledge of US FDA, ICH, EMA, MHRA regulations and guidance documents.
• Expertise in GxP systems and providing consultation from experience.
• Ability to manage projects and earn client confidence.

Responsibilities

• Represent the company in areas of quality assurance and GxP compliance.
• Consult and support management of CQA projects and audits.
• Develop and maintain QMS, CAPA, and training materials as needed.
• Travel as required and engage with clients at all levels.

Skills

FDA regulations

GxP systems

Regulatory compliance

Quality assurance

Project management

Job description

ProPharma Group in the United States seeks a Compliance and Quality Assurance Consultant (CQA) to support GxP compliance projects across GMP, GCP, and GLP domains. You will provide expert consultation, lead audits, and help develop and maintain quality management systems.

Travel may be required; strong knowledge of US FDA, ICH, EMA guidance; ability to mentor clients and coordinate with cross-functional teams; proficiency in English and another European language preferred.