GVP/GCP Auditor, Compliance & Quality Assurance

This is a fully remote position, open to applicants in Japan, +1 more country.

📋 Description

• Assist in the management of projects related to compliance and quality assurance.

• Offer consulting and contract services to clients concerning quality, regulatory, clinical, and safety matters.

• Implement quality assurance GVP/GCP compliance initiatives.

• Perform audits, develop QMS, oversee QA, and respond to regulatory agency actions.

• Aid in the execution and promotion of ProPharma Group's CQA program, policies, and strategies.

• Ensure adherence to GVP/GCP regulations and keep up with industry trends.

• Oversee and implement various compliance, quality assurance, and Quality and Compliance Consulting services.

⛳️ Requirements

• Proficiency in both Japanese and English.

• Familiarity with relevant PMDA, US FDA, ICH, EMA, and MHRA regulations and guidance documents.

• Expertise in GVP/GCP systems with the ability to provide consultation based on prior experience and system knowledge.

• Willingness and capability to travel as necessary.

• Strong interpersonal and communication abilities.

• Effective skills in written and oral communication.

• Capacity to manage and execute multiple compliance, quality assurance, and Quality and Compliance Consulting tasks.

• A strong quality orientation with high attention to detail.

• Excellent analytical skills.

• A bachelor's degree or comparable college degree in a scientific field at minimum.

• Eligibility, where applicable, to be registered as a Qualified Person (QP), Responsible Person (RP), and Responsible Person import (RPi).

• At least 10 years of relevant experience in quality assurance and regulatory/GxP compliance.

• Previous registration as a Qualified Person, where applicable.

• Solid working knowledge of GxP principles and Health Authority regulations.

• For primarily auditing-focused Consultant, CQA roles: at least 1 year of experience leading audits and recent auditing engagements, with a minimum of 5 audits performed in the past year documented in the candidate's audit log.

• A graduate degree (MSc/PhD) in a scientific discipline is preferred.

• Ability to accurately communicate information/instructions in English and one additional European language is preferred (for EU employees).

🏝️ Benefits

• Support for remote working.

• Hybrid working is encouraged for new hires located near an office.

• A workplace that is an Equal Opportunity Employer, committed to diversity, equity, and inclusion.