Quality Assurance Director [Sōseki] - Confidential & Exclusive

Position: Director, Quality Assurance (Pharmaceutical Industry)

Location: Tokyo, Japan

Compensation: 26M JPY (negotiable)

Employment Type: Full-time, permanent

About the Role

We are seeking an experienced and highly motivated Director of Quality Assurance to lead the quality strategy and compliance functions for our pharmaceutical operations in Japan. This position plays a critical role in ensuring product quality, patient safety, and regulatory compliance, while supporting the business in delivering innovative therapies to market.

Key Responsibilities

• Provide strategic leadership for Quality Assurance (QA) and Quality Control (QC) functions in alignment with global and local business objectives.

• Ensure compliance with Japanese regulatory requirements (PMDA, MHLW), as well as global GMP/GDP standards.

• Lead and oversee quality systems, including documentation, audits, inspections, deviation management, CAPA, and change control.

• Act as the primary quality representative for internal and external stakeholders, including health authorities.

• Drive continuous improvement initiatives to strengthen quality culture across the organization.

• Manage and mentor the QA/QC team, fostering collaboration, development, and performance excellence.

• Serve as the pharmacist-in-charge (総括製造販売責任者, Sōkatsu Seizō Hanbai Sekininsha) in accordance with Japanese regulatory requirements.

Qualifications

• Licensed Pharmacist in Japan (required).

• Eligible to serve as a 総括製造販売責任者 (Sōkatsu) under Japanese regulations.

• 10+ years of experience in pharmaceutical quality, including 5+ years in a leadership role.

• Deep understanding of GMP, GDP, and Japanese regulatory requirements.

• Proven track record of managing audits, inspections, and regulatory submissions.

• Strong leadership, communication, and stakeholder management skills.

• Business-level Japanese and English proficiency.

Compensation & Benefits

• Annual compensation in the ¥26 million range (negotiable based on experience and qualifications).

• Comprehensive benefits package, including health, pension, and transportation allowance.

• Hybrid work options and career development opportunities.