GxP Compliance Auditor & SOP Writer (Remote Friendly)

ProPharma; Raleigh (NC); Hybrid; USD 110,000 - 170,000; Full time

Job summary

ProPharma in the United States seeks a Compliance and Quality Assurance Consultant to support CQA projects and provide guidance on GMP/GxP compliance. You will help design, implement, and monitor quality systems, audits, and CAPA programs for biotech, pharma, and medical device clients.

Ideal candidates have 5+ years in QA/regulatory roles, strong knowledge of FDA/ICH/EU regulations, and the ability to travel.

Qualifications

• Knowledge of US FDA, ICH, EMA, MHRA regulations and guidance documents.
• Expertise in GxP systems and ability to consult based on experience.
• Ability to manage multiple compliance projects with strong planning.

Responsibilities

• Represent the company in quality assurance and GxP areas.
• Support management of CQA projects and client consulting.
• Develop QMS, QA oversight, auditing, and regulatory responses as assigned.

Skills

GxP compliance

FDA regulations

Regulatory affairs

Quality systems (QMS)

Auditing

Project management

Travel readiness

English + European language

Education

Bachelor’s degree in a scientific discipline

MSc or PhD preferred

QP/RP eligibility (EU) preferred

Job description

ProPharma in the United States seeks a Compliance and Quality Assurance Consultant to support CQA projects and provide guidance on GMP/GxP compliance. You will help design, implement, and monitor quality systems, audits, and CAPA programs for biotech, pharma, and medical device clients.

Ideal candidates have 5+ years in QA/regulatory roles, strong knowledge of FDA/ICH/EU regulations, and the ability to travel.