Senior Manager, Global Development Quality Lead – Japan

Key Responsibilities

Lead quality and compliance activities across GCP, GVP, Medical Affairs, and Regulatory Affairs for the Japan affiliate Provide strategic quality guidance and drive risk-based quality initiatives, including audits Lead and support inspection readiness and preparation for local operations Identify and drive process improvements aligned with quality objectives Manage quality issues and ensure appropriate escalation of significant non-compliance Provide expert guidance and training on international regulations and company quality standards Partner with local and global stakeholders to strengthen the quality management system Coach and mentor junior team members and/or take ownership of key quality processes Requirements Ideal Background Bachelor's degree or equivalent experience 8+ years of relevant experience in the pharmaceutical or healthcare industry Strong knowledge and practical application of GCP and/or GVP Background in quality/compliance or clinical development, with solid GCP/GVP expertise Experience managing complex quality and compliance issues Experience in training, supervision, line management, or staff development Strong project management, planning, and prioritization skills Experience with risk-based quality management and process improvement Strong communication and stakeholder management skills, including the ability to influence senior stakeholders Strong analytical, problem-solving, and collaborative skills Benefits Why Join?

Join a fast-growing global biopharmaceutical company with an innovative pipeline Take on a senior, high-visibility quality leadership role within the Japan affiliate Gain broad exposure across GCP, GVP, Medical, and Regulatory Affairs Work closely with global and Japan stakeholders in an international environment Play a key role in strengthening quality systems, inspection readiness, and compliance Opportunity to influence strategic quality initiatives and process improvements Hybrid working model in Tokyo Opportunity to develop and mentor others while continuing to grow as a quality leader