Associate Director - GCP/GVP Inspections

i‑Pharm Consulting; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

i‑Pharm Consulting in Boston, MA is seeking an experienced Associate Director of GCP/GVP Inspections to lead global health authority inspections for clinical and pharmacovigilance programs. The role requires coordinating with regulators and ensuring readiness across programs.

The incumbent will collaborate with EU regulatory bodies and the FDA, drive inspection readiness, and lead continuous process improvements through global, cross-functional teams.

Qualifications

• 8+ years of experience leading inspection readiness.
• Strong background working with international regulatory bodies.

Responsibilities

• Coordinate GCP/GVP inspection activity
• Drive inspection readiness, compliance, and continuous process improvement
• Coordinate cross-functional and global teams

Skills

Inspection leadership

Regulatory liaison

Job description

A global Pharmaceutical company is seeking an experienced Associate Director of GCP/GVP Inspections of to lead global health authority inspections for clinical and pharmacovigilance programs, They will be expected to have a strong background working with EU regulatory bodies and the FDA.

Responsibilities

• Coordinate GCP/GVP inspection activity
• Drive inspection readiness, compliance, and continuous process improvement
• Coordinate cross-functional and global teams

Qualifications

• 8+ years of experience leading inspection readiness
• Strong background working with international regulatory bodies