Quality Lead

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Position Overview:

The Quality Lead will oversee quality management for the Medical Information (MI) team in Japan, ensuring compliance with local and global regulatory and company standards. This role focuses on audit hosting, deviations, CAPA management, and Quality Management System (QMS) activities. The individual will be responsible for review and approval of deviation investigations, approving CAPAs, and ensuring adherence to high-quality standards.

Key Responsibilities:

•  Audits – Hosting client audits and/or managing external audits and inspection support
•  Quality Management System (QMS) – Maintain, update, and ensure compliance with QMS requirements.
•  Deviations – Review and approve deviation investigations, ensuring proper documentation and resolution.
•  CAPA Management – Review and approve CAPAs
•  Regulatory Compliance – Ensure all quality activities align with local and global regulatory standards.
•  Client Audits & Inspections – Act as the primary contact for client audits and regulatory inspections, representing ProPharma in quality matters.
•  Stakeholder Collaboration – Work closely with MI, Operational, and Client Services staff members
•  Risk Management & Continuous Improvement – Identify quality risks, escalate concerns to management, and recommend corrective actions.
•  Participation in Quality Committees – Support the Quality Manager in the Regional Quality Committee and act as a regional representative in the Global Quality Committee.
•  Ownership of the Region – Act as the key quality contact for Japan, with potential for regional expansion.
•  General Administration – Support documentation, reporting, and quality-related tasks.

Must-Have Qualifications:

•  Native Japanese speaker with business-level or higher English.
•  Audit hosting experience in a regulated environment.
•  Strong QMS knowledge and experience working extensively within a Quality Management System (Ideally an electronic quality management system (eQMS)).
•  Extensive experience managing deviations and CAPAs, with the ability to sign off and approve actions.
•  Ability to manage workload, communicate effectively across teams, and resolve quality-related challenges constructively.
•  Self-starter who can independently manage quality operations in Japan
•  5+ years Quality experience in pharmaceutical or medical device industry, or other regulated environment (e.g., Healthcare)