Global GRA Audits & Compliance Senior Manager

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

Job summary

Takeda in Cambridge, MA seeks a Senior Manager, GRA Audits, Inspections and Compliance to lead global GCP audits and inspections, ensuring readiness and regulatory compliance. The role partners with Regulatory Leads and cross-functional teams to align initiatives and improve processes across neuroscience, oncology, GI and other areas.

You will drive continuous improvement, manage post-audit follow-up, and support live audits, with a focus on harmonizing systems and reducing non-compliance risks.

Qualifications

• Bachelor’s degree in a science- or business-related field.
• Minimum of 5 years of experience in the pharmaceutical industry, including at least 3 years in clinical trial management, Regulatory Affairs, Quality Assurance and/or Compliance.
• Deep knowledge of global regulations related to clinical trials across major markets, with cross-functional and multicultural experience.
• Experience using the Veeva platform, including Veeva RIM and Veeva 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.
• Act as a liaison among GCP Compliance, GCP Excellence and Clinical Program Quality teams.
• Monitor and support regulatory compliance performance across therapeutic areas.
• Align Regulatory Affairs initiatives with stakeholders across the organization.
• Build collaborative relationships to develop global regulatory processes and systems.
• Lead efforts to simplify and optimize business processes and platforms.

Skills

GCP audits

Regulatory affairs

Quality assurance

Veeva RIM

Veeva Clinical

Cross-functional collaboration

Communication skills

Risk management

Project management

Education

Bachelor's degree in science or business

Tools

Veeva Platform

Job description

Takeda in Cambridge, MA seeks a Senior Manager, GRA Audits, Inspections and Compliance to lead global GCP audits and inspections, ensuring readiness and regulatory compliance. The role partners with Regulatory Leads and cross-functional teams to align initiatives and improve processes across neuroscience, oncology, GI and other areas.

You will drive continuous improvement, manage post-audit follow-up, and support live audits, with a focus on harmonizing systems and reducing non-compliance risks.