Global GCP Audits & Compliance Senior Manager

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

Job summary

Takeda Cambridge, MA is seeking a Senior Manager, GRA Audits, Inspections and Compliance to lead global management of GCP audits and inspections within Regulatory Affairs. You will ensure readiness, provide live support during audits, manage post-audit follow-up and drive process improvements across Global Regulatory Affairs.

The role requires a Bachelor’s in science or business, 5+ years in pharma with 3+ in regulatory/compliance, experience with Veeva (RIM and Clinical), strong communication,

Qualifications

• Bachelor's degree in a science- or business-related field.
• Minimum of 5 years in pharma, including at least 3 years in clinical trial management, Regulatory Affairs, Quality Assurance or Compliance.
• Deep knowledge of global regulatory requirements for clinical trials across major markets.
• Experience using the Veeva platform, including RIM and Clinical.

Responsibilities

• Manage, coordinate and follow up on GCP audits and inspections globally.
• Support audit/readiness and provide live support during audits and inspections.
• Lead post-audit and post-inspection follow-up activities.
• Collaborate with GCP Compliance, GCP Excellence and Clinical Program Quality teams.
• Align regulatory initiatives with stakeholders and drive process improvements.
• Build relationships to implement global regulatory processes and systems.

Skills

GCP audits

Regulatory affairs

Quality Assurance

Cross-functional collaboration

Veeva platform (RIM/Clinical)

Communication skills

Education

Bachelor's degree in science or business

Tools

Veeva RIM

Veeva Clinical

Job description

Takeda Cambridge, MA is seeking a Senior Manager, GRA Audits, Inspections and Compliance to lead global management of GCP audits and inspections within Regulatory Affairs. You will ensure readiness, provide live support during audits, manage post-audit follow-up and drive process improvements across Global Regulatory Affairs.

The role requires a Bachelor’s in science or business, 5+ years in pharma with 3+ in regulatory/compliance, experience with Veeva (RIM and Clinical), strong communication,