Senior Manager, Inspection Readiness
Genmab
June 26, 2026
Remote friendly (Princeton, NJ)
United States
Operations
Responsibilities
Trial Inspection Readiness and Preparation
- Design and optimize tools and processes for trial inspection readiness using digitalization and automation.
- Support study teams with GCP/clinical compliance (risk mitigation and monitoring; follow-up and closure of GCP serious breaches or other non/reportable persistent non-compliance and quality events) to increase sponsor oversight.
- Assess compound/trial inspection readiness by analyzing key metrics and generating actionable insights.
- Develop and deliver GCP inspection readiness training/tools for Clinical Trial Operations and other stakeholders.
- Collaborate with GCP QA and support operational inspection setup during sponsor and site/vendor GCP inspections.
- Conduct lessons learned from inspection readiness, preparations, and outcomes.
Quality Events Oversight
- Maintain oversight and ensure compliance of Clinical Trial Delivery quality events and effectiveness checks.
- Trend findings from audits, inspections, and Quality Events relevant to Clinical Trial Operations stakeholders.
Clinical Compliance
- Support ICH-GCP, regulatory requirements (FDA, EMA, MHRA, PMDA, NMPA), and Genmab SOPs.
- Lead and contribute to cross-functional process/system enhancement and innovation initiatives.
Requirements
- MSc in Life Sciences, Pharmacy, Medicine, or related.
- 8+ years in Clinical Operations, Clinical Quality, Inspection Readiness, or Clinical Compliance (pharma/biotech).
- Strong understanding of clinical trial processes, ICH-GCP & regulations, and clinical drug development lifecycle.
- Project management skills; experience mentoring colleagues.
- Excellent written/verbal communication; proactive risk identification and issue resolution.
- Strong stakeholder management in a complex global matrix.
Benefits (U.S. within first year)
- 401(k) 100% match on first 6%.
- Medical/dental/vision; voluntary critical illness, accident, hospital indemnity.
- Paid vacation/sick leave/holidays; 12 weeks discretionary paid parental leave.
- Backup care and family support; financial wellness and emotional well-being support.
- Commuter benefits, tuition reimbursement, Lifestyle Spending Account.
Trial Inspection Readiness and Preparation
- Design and optimize tools and processes for trial inspection readiness using digitalization and automation.
- Support study teams with GCP/clinical compliance (risk mitigation and monitoring; follow-up and closure of GCP serious breaches or other non/reportable persistent non-compliance and quality events) to increase sponsor oversight.
- Assess compound/trial inspection readiness by analyzing key metrics and generating actionable insights.
- Develop and deliver GCP inspection readiness training/tools for Clinical Trial Operations and other stakeholders.
- Collaborate with GCP QA and support operational inspection setup during sponsor and site/vendor GCP inspections.
- Conduct lessons learned from inspection readiness, preparations, and outcomes.
Quality Events Oversight
- Maintain oversight and ensure compliance of Clinical Trial Delivery quality events and effectiveness checks.
- Trend findings from audits, inspections, and Quality Events relevant to Clinical Trial Operations stakeholders.
Clinical Compliance
- Support ICH-GCP, regulatory requirements (FDA, EMA, MHRA, PMDA, NMPA), and Genmab SOPs.
- Lead and contribute to cross-functional process/system enhancement and innovation initiatives.
Requirements
- MSc in Life Sciences, Pharmacy, Medicine, or related.
- 8+ years in Clinical Operations, Clinical Quality, Inspection Readiness, or Clinical Compliance (pharma/biotech).
- Strong understanding of clinical trial processes, ICH-GCP & regulations, and clinical drug development lifecycle.
- Project management skills; experience mentoring colleagues.
- Excellent written/verbal communication; proactive risk identification and issue resolution.
- Strong stakeholder management in a complex global matrix.
Benefits (U.S. within first year)
- 401(k) 100% match on first 6%.
- Medical/dental/vision; voluntary critical illness, accident, hospital indemnity.
- Paid vacation/sick leave/holidays; 12 weeks discretionary paid parental leave.
- Backup care and family support; financial wellness and emotional well-being support.
- Commuter benefits, tuition reimbursement, Lifestyle Spending Account.