Senior Manager, Inspection Readiness - GCP

Genmab; Princeton (NJ); Presencial; USD 131.000 - 196.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) match

Health benefits

Voluntary plans

Paid time off

Parental leave

Commuter benefits

Tuition reimbursement

Lifestyle Spending Account

Descripción de la vacante

Genmab is seeking a Senior Manager, Inspection Readiness - Good Clinical Practice, to embed GCP compliance into clinical trials and oversight. You will lead inspection-readiness initiatives, guide study teams, and partner with GCP QA to strengthen sponsor oversight and risk mitigation.

This is an individual contributor role reporting to the Director, Trial Delivery Team Lead, with a focus on process improvements, training, and cross-functional collaboration in a global, matrix organization.

Formación

• 8+ years of experience in Clinical Operations, Clinical Quality, Inspection Readiness or Clinical Compliance.
• Strong understanding of ICH-GCP guidelines and applicable regulations.
• Excellent written and verbal communication skills.
• Strong project management skills and knowledge of relevant tools and processes.
• Experience mentoring colleagues and supporting their professional development.
• Ability to proactively identify risks and develop mitigation strategies.
• Strong stakeholder management across functions in a global matrix organization.

Responsabilidades

• Design and optimize tools and processes for trial inspection readiness with digitalization.
• Guide study teams in maintaining trial inspection readiness with GCP compliance and risk management.
• Conduct ongoing assessments of inspection readiness by analyzing key metrics.
• Lead the development and delivery of GCP inspection readiness training and tools.
• Collaborate with GCP QA to support inspection setups during inspections.
• Facilitate lessons-learned activities based on inspection readiness outcomes.

Conocimientos

Project management

Communication

Stakeholder management

Educación

Bachelor’s or Master’s in Life Sciences/Pharmacy/Medicine

Descripción del empleo

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off 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.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

Role

The Senior Manager, Inspection Readiness - Good Clinical Practice, plays a key role in supporting the Clinical Trial Operations organization by embedding clinical compliance and inspection readiness into clinical trials and service provider oversight. This position is essential for maintaining a high level of clinical trial inspection readiness while ensuring adherence to Good Clinical Practice (GCP) guidelines and applicable regulatory requirements. The individual will also lead process improvement initiatives.

This is an individual contributor role at the Senior Manager level, reporting to the Director, Trial Delivery Team Lead.

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 in maintaining trial inspection readiness by providing GCP and clinical compliance support, including risk identification, mitigation and monitoring; management of serious GCP breaches and other reportable or non-reportable persistent non-compliance events; and follow-up and closure of quality events, thereby strengthening sponsor oversight.
• Conduct ongoing assessments of compound and/or trial inspection readiness by analyzing key metrics to generate actionable insights.
• Lead the development and delivery of GCP inspection readiness training and tools for Clinical Trial Operations and other key stakeholders.
• Collaborate closely with GCP QA to support the operational framework and inspection setup during sponsor, site and vendor GCP inspections.
• Facilitate lessons-learned activities based on inspection readiness assessments, preparations and outcomes within Clinical Trial Operations.

Quality Events Oversight

• Maintain oversight of Clinical Trial Delivery quality events and effectiveness checks, ensuring compliance with applicable requirements.
• Analyze trends in findings from audits, inspections and quality events, as relevant to Clinical Trial Operations and other key stakeholders.

Clinical Compliance

• Provide guidance and support on ICH-GCP guidelines, applicable regulatory requirements (e.g., FDA, EMA, MHRA, PMDA and NMPA) and Genmab SOPs.
• Lead and contribute to functional and/or cross-functional business process improvements, system enhancements and innovative initiatives.

Requirements

• Bachelor’s (BSc) or master’s degree (MSc) in Life Sciences, Pharmacy, Medicine or a related discipline.
• A minimum of 8 years of experience in Clinical Operations, Clinical Quality, Inspection Readiness or Clinical Compliance within the pharmaceutical or biotechnology industry.
• Strong understanding of clinical trial processes, ICH-GCP guidelines, applicable regulations and the clinical drug development lifecycle.
• Strong project management skills and knowledge of relevant tools and processes.
• Experience mentoring colleagues and supporting their professional development.
• 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 in a complex, global, matrix organization.

For US based candidates, the proposed salary band for this position is as follows:

$130,720.00---$196,080.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When You Join Genmab, You’re Joining a Culture That Supports Your Physical, Financial, Social, And Emotional Wellness. Within The First Year, Regular Full-time U.S. Employees Are Eligible For

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

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

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

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Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.