Senior Manager, Global Development Quality Lead Japan

Location: Japan; Work model: Hybrid

Company

Develops life-changing medicines for people with serious diseases through science and innovation.

What you will do

• Lead quality and compliance activities for GCP, GVP, Medical Affairs, and Regulatory Affairs within the Japan affiliate.
• Build partnerships with local and global stakeholders and drive proactive, risk-based quality initiatives, including audits.
• Optimize inspection readiness and support preparation for inspections of local affiliate operations.
• Lead quality-focused projects and process improvement initiatives.
• Manage issue resolution and escalate serious non-compliance through established processes.
• Provide regulatory guidance and training while coaching, mentoring, or line-managing team members.

Requirements

• Bachelor’s degree or equivalent experience.
• At least 8 years of relevant healthcare or pharmaceutical industry experience.
• Advanced knowledge and practical application of GCP and/or GVP guidelines, including complex quality and compliance issues.
• Experience in quality, compliance, or clinical development roles with GCP/GVP expertise.
• Experience with training, supervision, line management, or staff development.
• Strong project management, stakeholder engagement, communication, prioritization, and digital literacy skills.

Culture & Benefits

• Work in a science-driven organization focused on improving patient outcomes.
• Inclusive workplace with equal employment opportunity.
• Competitive total rewards package that may include bonuses, equity awards, retirement benefits, insurance, paid time off, and family support benefits.
• Background checks may verify identity, right to work, and educational qualifications where required by local law.