Global GVP Compliance Lead

Takeda; Boston (MA); On-site; USD 154,000 - 243,000; Full time

Job summary

Takeda in Cambridge, MA is seeking an Associate Director, International GVP Compliance to lead GVP compliance across international regions. You will partner with LOCs, PSPV, and Global teams to translate global strategies into regional practices, strengthening quality systems and inspection readiness.

The role focuses on risk-based compliance, CAPA management, and continuous improvement to protect patient safety and regulatory integrity.

Qualifications

• Scientific or allied health qualification (BSc) required.
• 7+ years in pharmaceutical/healthcare industry; 4+ years in PV quality, compliance, or PV operations.
• Strong knowledge of GVP, ICH E2, and US CFR.
• Experience supporting GVP audits and regulatory inspections.
• Excellent written/verbal communication and ability to influence in matrix environments.

Responsibilities

• Lead regional implementation of global GVP compliance strategies across LOCs.
• Provide guidance on regulatory expectations, quality system requirements, and inspection readiness.
• Oversee core GVP Quality System processes: deviations, investigations, CAPA, change control.
• Lead investigations and root-cause analyses with patient-safety focus.
• Ensure timely escalation of critical issues and support CAPA effectiveness.

Skills

GVP knowledge

Regulatory compliance

Pharmacovigilance investigations

Risk assessment

Cross-functional collaboration

Education

BSc or equivalent

Advanced degree preferred

Job description

Takeda in Cambridge, MA is seeking an Associate Director, International GVP Compliance to lead GVP compliance across international regions. You will partner with LOCs, PSPV, and Global teams to translate global strategies into regional practices, strengthening quality systems and inspection readiness.

The role focuses on risk-based compliance, CAPA management, and continuous improvement to protect patient safety and regulatory integrity.