Senior Manager, Global Development Quality Lead Japan

About the role

Regeneron, a biotechnology company developing medicines for serious diseases, is looking for a Senior Manager, Global Development Quality Lead for its Japan affiliate. The role sits in the Global Development Quality & Regulatory Compliance team and works in a hybrid model, driving quality and compliance in local operations through guidance and leadership of the quality management system supporting GCP, GVP, Medical and Regulatory Affairs.

Key responsibilities

• Lead quality and compliance activities for GCP, GVP, Medical and Regulatory Affairs at the Japan affiliate.
• Build strategic partnerships and drive proactive, risk-based quality initiatives, including audits, with key stakeholders.
• Optimize inspection readiness and support inspection preparation for local affiliate operations.
• Contribute to process improvement initiatives and lead projects aligned with quality objectives.
• Manage issue resolution and escalate serious non-compliances through established processes.
• Provide expert guidance, training and support on international regulations and Regeneron standards.
• Line manage, coach and mentor junior team members, or act as process owner as assigned.

Required profile

• Bachelor's degree (or equivalent experience) and at least 8 years of relevant healthcare/pharmaceutical industry experience.
• Experience in quality/compliance or clinical development roles, with expertise in GCP.
• Proven ability to train, supervise, line manage and develop staff.
• Business-level fluency in Japanese and English.
• Understanding of risk-based quality management and process improvement.

Required skills

• Advanced knowledge and application of GCP guidelines, including managing complex quality and compliance issues.
• Strong project management, planning, prioritization and time management skills.
• Advanced digital literacy, including Microsoft Office suite.
• Effective communication and stakeholder engagement, with the ability to influence senior leaders.

The company states that many roles require on-site performance and that background checks may be carried out. It also describes a total rewards package that may include bonuses, equity awards, pension or retirement benefits, insurance and paid time off, depending on country and role.