Senior GVP/GCP Auditor: Compliance & Quality Assurance

ProPharma; Melbourne; Hybrid; AUD 120,000 - 160,000; Full time

Job summary

ProPharma is seeking a Clinical/PV Consultant and Auditor, Compliance and Quality Assurance (CQA) to support QA and regulatory projects, ensuring GVP/GCP compliance and quality system excellence. The role involves consulting, audits, QMS development, and promotion of the CQA program across client engagements.

The position requires strong Japanese and English fluency, deep regulatory knowledge, and willingness to travel; a scientific degree with QP/RP eligibility is preferred.

Qualifications

• Bachelor’s degree or equivalent in a scientific discipline.
• MSc or PhD preferred.
• Eligible to be registered as QP, RP and RPi.

Responsibilities

• Support QA and regulatory/GxP compliance projects.
• Provide consulting on GVP/GCP and quality systems.
• Promote ProPharma's CQA program and strategies.
• Travel as required.
• Auditing, QMS development, QA oversight, regulatory actions.

Skills

Japanese fluency

English fluency

Regulatory knowledge

GxP compliance

Auditing

Project management

Interpersonal skills

Technical writing

Communication skills

Travel willingness

Education

Bachelor's degree

Advanced degree preferred

QP/RP eligibility

Job description

ProPharma is seeking a Clinical/PV Consultant and Auditor, Compliance and Quality Assurance (CQA) to support QA and regulatory projects, ensuring GVP/GCP compliance and quality system excellence. The role involves consulting, audits, QMS development, and promotion of the CQA program across client engagements.

The position requires strong Japanese and English fluency, deep regulatory knowledge, and willingness to travel; a scientific degree with QP/RP eligibility is preferred.