Senior Manager, Inspection Readiness - GCP

At Genmab, we are dedicated to building extraordinary futures by developing antibody products and groundbreaking KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

About the Role

The Senior Manager, Inspection Readiness plays a key role in supporting the Clinical Trial Operations organization by contributing to building clinical compliance and inspection readiness into trials and with service providers. This position is essential for maintaining high-quality clinical trial inspection readiness while ensuring adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements. This individual will also lead process improvements. This is an individual contributor role at the Senior Manager level, with no direct people management responsibilities.

Responsibilities

• Trial Inspection Readiness and Preparation
  • 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, GCP serious breaches or other non/reportable persistent non-compliance events, quality events - follow-up and closure, contributing to increased sponsor oversight.
  • Drive continuous assessments of compound and/or trial inspection readiness by analyzing key metrics to interpret and generate actionable insights.
  • Lead the development and delivery of GCP inspection readiness training/tools for Clinical Trial Operations and other key stakeholders.
  • Collaborate closely with GCP QA and support the operational framework and inspection setup during sponsor and site/vendor GCP inspections.
  • Develop and conduct lessons learned from inspection readiness, preparations and outcomes within Clinical Trial Operations.
• Quality Events Oversight
  • Maintain oversight and drive compliance of Clinical Trial Delivery quality events and effectiveness checks.
  • Complete trending of findings from audits, inspections and Quality Events as relevant for roles within Clinical Trial Operations and other key stakeholders.
• Clinical Compliance
  • Provide support related to ICH-GCP, regulatory requirements (e.g. FDA, EMA, MHRA, PMDA, NMPA) and Genmab SOPs.
  • Lead and contribute in functional and/or cross-functional business processes or system enhancement/innovative initiatives.

Requirements

• Master’s (MSc) degree in Life Sciences, Pharmacy, Medicine or a related discipline.
• Minimum of 8 years of experience in Clinical Operations, Clinical Quality, Inspection Readiness or Clinical Compliance role within the pharmaceutical or biotechnology industry.
• Strong understanding of clinical trial processes, ICH-GCP & regulations, and the clinical drug development lifecycle.
• Project management skills and knowledge of tools and processes.
• Experience mentoring and supporting the development of colleagues.
• Excellent written and verbal communication skills.
• Ability to proactively identify risks, develop mitigation strategies, and effectively resolve issues.
• Strong stakeholder management skills with the ability to collaborate effectively across functions working in a complex, global, and matrix organization.

Pay

The proposed gross annual base salary range for this position, in the primary location, based on a full-time schedule is: DKK 687,888.00 – 1,031,832.00. The final salary offer will depend on several factors, including your skills, qualifications, and experience. In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

Benefits

When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to:

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs

Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process.