Senior Manager, Global GCP Audits & Compliance

Takeda Pharmaceutical Co.; Cambridge (MA); On-site; USD 137,000 - 215,000; Full time

Job summary

Takeda Pharmaceutical Co. in Cambridge, MA seeks a Senior Manager, GRA Audits, Inspections and Compliance to lead global regulatory audits and inspections coordination across Therapeutic areas, ensuring readiness and compliant practices.

The role partners with International Clinical Trial Regulatory Leads and Global Regulatory Leads to support audit readiness, provide live support, and manage post-audit follow-up while driving continuous improvement in regulatory processes and systems.

Qualifications

• Bachelor's degree in a science- or business-related field.
• At least 5 years in the pharmaceutical industry with 3+ years in clinical trial management, Regulatory Affairs, Quality Assurance or Compliance.
• Deep knowledge of global clinical trial regulations with cross-functional experience.
• Experience using Veeva platforms (RIM and Clinical).
• Strong communication skills to convey complex issues to diverse stakeholders.

Responsibilities

• Manage, coordinate and follow up on GCP audits and inspections globally.
• Partner with International Clinical Trial Regulatory Leads and Global Regulatory Leads on readiness.
• Act as liaison among GCP Compliance, GCP Excellence and Clinical Program Quality teams.
• Monitor and support regulatory compliance performance across therapeutic areas.
• Align GRA initiatives with stakeholders and develop regulatory processes and systems.
• Build relationships to implement global regulatory processes and drive automation where possible.
• Lead efforts to simplify and optimize business processes and platforms.

Skills

Cross-functional collaboration

Stakeholder communication

Risk management

Strategic thinking

Education

Bachelor's degree in a science- or business-related field

Tools

Veeva RIM

Veeva Clinical

Job description

Takeda Pharmaceutical Co. in Cambridge, MA seeks a Senior Manager, GRA Audits, Inspections and Compliance to lead global regulatory audits and inspections coordination across Therapeutic areas, ensuring readiness and compliant practices.

The role partners with International Clinical Trial Regulatory Leads and Global Regulatory Leads to support audit readiness, provide live support, and manage post-audit follow-up while driving continuous improvement in regulatory processes and systems.