Senior GCP Inspection Office Lead

Genmab; Princeton (NJ); On-site; USD 156,000 - 234,000; Full time

Benefits offered by this job

401(k) Plan with 100% match up to 6%

Health, dental and vision insurance

Voluntary plans: critical illness, etc

Paid vacation, sick leave, holidays, 2

Parental leave and wellness programs

Job summary

Genmab seeks a senior GCP Inspection Office lead to drive day-to-day GCP Quality activities and oversee inspection readiness across global clinical programs. You will collaborate with multiple QA and study teams to ensure compliant processes and timely regulatory responses.

The role requires in-depth knowledge of EMA, FDA and PMDA expectations, with proven leadership in inspections and the ability to educate others in GCP practices. A dynamic, international environment awaits.

Qualifications

• 10+ years of experience in a GCP Quality function or similar.
• Deep expertise in GCP processes and the EMA, PMDA and FDA requirements.
• Demonstrated leadership in regulatory inspections and health authority interactions.
• Experience as Lead Auditor within GCP is an advantage

Responsibilities

• Report to Director and Team Lead Inspection Office R&D Quality.
• Oversee GCP inspection readiness across cross-functional clinical study teams.
• Lead end-to-end inspection planning and execution including logistics and stakeholder coordination.
• Lead mock inspections for high-risk trials across Genmab locations.
• Coordinate inspection requests to SMEs and guide timely, effective responses.
• Create and revise tools and SOPs for inspection readiness and management.
• Ensure Veeva records are updated for inspection documentation.

Skills

GCP Quality

Lead Auditor

Regulatory inspections

GCP processes

Education

MS/BS in Natural Science

Job description

Genmab seeks a senior GCP Inspection Office lead to drive day-to-day GCP Quality activities and oversee inspection readiness across global clinical programs. You will collaborate with multiple QA and study teams to ensure compliant processes and timely regulatory responses.

The role requires in-depth knowledge of EMA, FDA and PMDA expectations, with proven leadership in inspections and the ability to educate others in GCP practices. A dynamic, international environment awaits.