Director Global Regulatory Affairs, Audits, Inspections and Compliance (Product Lifecycle Management)

About the role

Takeda is looking for a Director of Global Regulatory Affairs, Audits, Inspections and Compliance (GRAIC) focused on Product Lifecycle Management, based in Zurich. The role provides strategic leadership to strengthen regulatory compliance and inspection readiness across global and regional operations, drives a compliance culture and concentrates team effort on the highest-risk and highest-value activities. It leads audit and inspection support from readiness and execution through post-inspection follow-up and continuous improvement.

Key responsibilities

• Lead GRA audit and inspection readiness, execution, follow-up and continuous improvement
• Act as the key GRA contact for Global and R&D Quality on audits, inspections and regulatory compliance matters
• Lead and develop regionally aligned team members and guide cross-functional and regional partners
• Assess new and revised global regulatory GxP and compliance requirements and their operational impact
• Develop and monitor GRA metrics on regulatory commitments, audits, inspections and Health Authority requests
• Identify and communicate compliance risks, issues and trends, and oversee issue resolution and CAPAs

Required profile

• Bachelor's degree in a science or business-related field; MSc or PhD preferred
• 12+ years of pharmaceutical industry experience, including at least 3 years in Regulatory Affairs, R&D and/or Quality/Compliance
• Minimum 3+ years of people leadership experience
• Experience working across functions, regions and cultures in a global matrix environment

Required skills

• Strong expertise in audits, inspections, regulatory compliance and inspection readiness
• Knowledge of global Health Authorities, PV, license maintenance, product approval and lifecycle processes in the USA, EU, UK, Japan, China and Brazil
• Experience with Veeva RIM, Veeva Quality, TrackWise and Microsoft platform solutions