Senior Manager, Inspection Readiness - GCP
Genmab
August 18, 2026
Remote friendly (Princeton, NJ)
United States
Operations
Responsibilities:
- Design and optimize tools and processes for trial inspection readiness, leveraging digitalization and automation to improve efficiency and compliance.
- Guide study teams to ensure trial inspection readiness by providing GCP and clinical compliance support, including risk mitigation and monitoring, handling GCP serious breaches or other persistent non-compliance events, and quality event follow-up and closure to increase sponsor oversight.
- Drive continuous assessments of compound and/or trial inspection readiness by analyzing key metrics and generating actionable insights.
- Lead development and delivery of GCP inspection readiness training/tools for Clinical Trial Operations and other key stakeholders.
- Collaborate with GCP QA and support operational framework and inspection setup during sponsor and site/vendor GCP inspections.
- Develop and conduct lessons learned from inspection readiness, preparations, and outcomes.
- Maintain oversight and drive compliance of Clinical Trial Delivery quality events and effectiveness checks; trend findings from audits, inspections, and Quality Events.
- Provide support related to ICH-GCP, regulatory requirements (FDA, EMA, MHRA, PMDA, NMPA) and Genmab SOPs.
- Lead and contribute in functional/cross-functional business processes and system enhancement/innovative initiatives.
Requirements:
- MSc in Life Sciences, Pharmacy, Medicine, or related discipline.
- Minimum 8 years’ experience 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; knowledge of tools and processes.
- Experience mentoring colleagues.
- Excellent written and verbal communication.
- Ability to proactively identify risks, develop mitigation strategies, and resolve issues.
- Strong stakeholder management in a complex global matrix organization.
Benefits:
- Pension
- Health insurance and wellness benefits
- Paid time off
- Employee support programs
- Design and optimize tools and processes for trial inspection readiness, leveraging digitalization and automation to improve efficiency and compliance.
- Guide study teams to ensure trial inspection readiness by providing GCP and clinical compliance support, including risk mitigation and monitoring, handling GCP serious breaches or other persistent non-compliance events, and quality event follow-up and closure to increase sponsor oversight.
- Drive continuous assessments of compound and/or trial inspection readiness by analyzing key metrics and generating actionable insights.
- Lead development and delivery of GCP inspection readiness training/tools for Clinical Trial Operations and other key stakeholders.
- Collaborate with GCP QA and support operational framework and inspection setup during sponsor and site/vendor GCP inspections.
- Develop and conduct lessons learned from inspection readiness, preparations, and outcomes.
- Maintain oversight and drive compliance of Clinical Trial Delivery quality events and effectiveness checks; trend findings from audits, inspections, and Quality Events.
- Provide support related to ICH-GCP, regulatory requirements (FDA, EMA, MHRA, PMDA, NMPA) and Genmab SOPs.
- Lead and contribute in functional/cross-functional business processes and system enhancement/innovative initiatives.
Requirements:
- MSc in Life Sciences, Pharmacy, Medicine, or related discipline.
- Minimum 8 years’ experience 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; knowledge of tools and processes.
- Experience mentoring colleagues.
- Excellent written and verbal communication.
- Ability to proactively identify risks, develop mitigation strategies, and resolve issues.
- Strong stakeholder management in a complex global matrix organization.
Benefits:
- Pension
- Health insurance and wellness benefits
- Paid time off
- Employee support programs