Senior Manager, Global GCP Audits & Compliance

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

Job summary

Takeda Pharmaceutical Company Limited in Cambridge, MA is seeking a Senior Manager for GRA Audits, Inspections and Compliance (GRAIC) to lead global audits and drive regulatory readiness across programs.

The role partners with regional leads, aligns regulatory initiatives, and champions process improvements, with a focus on cross-functional collaboration and risk mitigation within a dynamic, matrixed organization.

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 and/or Compliance.
• Deep knowledge of global clinical trial regulations across major markets, with practical experience working cross-functionally and across regions in multicultural, matrixed organizations.
• Experience using the Veeva platform, including Veeva RIM and Veeva Clinical.
• Clear and effective communication skills, with the ability to synthesize and communicate complex issues to diverse internal and external stakeholders, both verbally and in writing.
• Ability to proactively identify and anticipate risks of non-compliance in a complex environment.

Responsibilities

• Manage, coordinate and follow up on GCP audits and inspections globally, helping ensure readiness and compliance.
• Partner with International Clinical Trial Regulatory Leads and Global Regulatory Leads to support audit and inspection readiness.
• Act as a liaison among GCP Compliance, GCP Excellence and Clinical Program Quality teams.
• Monitor and support global regulatory compliance performance for Global Regulatory Leads across therapeutic areas.
• Align Global Regulatory Affairs initiatives with stakeholders across the organization.
• Build collaborative relationships to develop and implement global regulatory processes and systems.
• Lead efforts to simplify and optimize business processes and platforms, including automation opportunities.

Skills

Regulatory affairs knowledge

Quality assurance experience

Clinical trial management

Cross-functional collaboration

Strategic thinking

Education

Bachelor's degree in science or business

Tools

Veeva Platform (RIM)

Job description

Takeda Pharmaceutical Company Limited in Cambridge, MA is seeking a Senior Manager for GRA Audits, Inspections and Compliance (GRAIC) to lead global audits and drive regulatory readiness across programs.

The role partners with regional leads, aligns regulatory initiatives, and champions process improvements, with a focus on cross-functional collaboration and risk mitigation within a dynamic, matrixed organization.