Associate Director Of Clinical Quality Assurance (CQA) (Biopharma)

TL;DR

Associate Director of Clinical Quality Assurance (CQA) (Biopharma): Ensuring quality and regulatory compliance for clinical trials in the Japan and APAC regions with an accent on GCP standards and risk-based quality systems. Focus on performing audits of investigator sites and vendors, managing regulatory inspections, and developing SOPs to maintain high compliance standards.

Location: Hybrid, Tokyo, Japan

Company

A global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Serve as the GCP Subject Matter Expert (SME) for Japan and the APAC region.
• Implement and manage strategic audit plans for investigator sites, vendors, and internal processes.
• Lead the company's representation during regulatory agency inspections.
• Maintain a risk-based quality system and manage regional quality documentation in Veeva QMS and Vault.
• Collaborate with cross-functional groups to identify and mitigate GCP quality and compliance issues.
• Provide coaching and support to staff to develop auditing resources.

Requirements

• BS degree in Biology, Chemistry, or related life sciences with 7-10 years of experience; advanced degree (MS, PhD, MBA) preferred.
• Proven experience managing regulatory agency inspections and preparing internal staff.
• Extensive GCP audit experience, including external audits of CROs, sites, and laboratories.
• Deep knowledge of ICH E6 Guidelines and risk-based quality systems.
• Solid experience with clinical trial Phases I-IV (specifically Phase III), NDAs, and MAAs.
• Ability to travel domestically and internationally, approximately 25%-30%.

Culture & Benefits

• Modern office in central Tokyo with a flexible free-address system.
• Hybrid work environment with advanced IT support for seamless collaboration.
• Flexible working hours and comprehensive leave policies.
• Competitive compensation including retirement plans, stock options, and ESPP.
• Career development via LinkedIn Learning and specialized professional training.
• Access to AI-powered learning tools and digital assistants.