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Jobs · New Jersey

Director of GCP Quality

Genmab · Princeton, NJ · 2 days ago
HybridFull-time

About R&D Quality

R&D Quality encompasses four teams: GCLP/GLP Quality, PV Quality, Audit Calibration, and GCP Quality. R&D Quality has a large range of stakeholders, and we have an important role in delivering our 2030 vision to transform the future of cancer treatment.

The Role

In the role as Director of GCP Quality you will be driving day-to-day GCP Quality activities including audit together with a dedicated and highly skilled team. Furthermore, you will be taking up the role as GCP Inspection QA lead. The role requires profound understanding of how the GCP requirements are applied into practice, especially with focus on the European requirements and interpretation of ICH GCP R3 and Computerized Systems in Clinical Trials. The role includes hands on GCP Quality activities such as support to our many stakeholders as well as performing audits alone or together with own team members or with support from neighboring teams. You become a key member of the R&D Quality leadership team that together drives people engagement, setting strategies and ensuring R&D Quality deliverables. The role requires strong collaboration capabilities in an international setting across various QA departments as well across the company with target stakeholders such as Clinical Trial Operations, Clinical Data, Integration & Reporting, Digital Development, Medical, GDS&PV, and Regulatory Affairs.

Key Responsibilities

  • Develop and maintain the GCP Quality strategies in collaboration with the R&D Quality leadership team
  • Lead, mentor and manage the GCP Quality team and ensure adequate training and development opportunities for the team
  • Foster communication with relevant stakeholders and the teams within R&D Quality
  • Obtain partnership with Director of GCLP/GLP Quality and the Director of Audit Calibration
  • Ensure that GCP compliance in alignment with Genmab's Quality Policy, procedures and regulatory requirements
  • Maintain a risk-based approach for conducting trial site audits, process audits and audits of service providers
  • Develop and execute the annual GCP audit plan in partnership with GCLP/GLP Quality and Audit Calibration
  • Oversee and coordinate regulatory GCP inspections, including pre-inspection preparation and post inspection follow ups
  • Drive standardization, harmonization, and scalability of GCP Quality processes
  • Ensure compliance with global GxP standards, regulatory requirements, and Genmab Quality Systems
  • Lead quality improvement initiatives to enhance processes and procedures
  • Review and contribution to Standard Operating Procedures (SOPs) and approve QMS documents as applicable
  • Deliver input to IT systems/solutions used in clinical activities via directions from Digital QA
  • Manage and lead quality assurance activities, including risk assessment, deviation management, and Corrective and Preventive Actions (CAPA) processes
  • Develop and deliver training programs for internal teams and external partners in partnership with Quality Strategy
  • Monitor industry trends, regulatory updates, and best practices to support the organization's quality standards are up to date
  • Participate in developing, maintaining, and improving the Genmab Quality Management System (QMS)
  • Deliver input to the Quality Management Review, as applicable
  • Assist Head of R&D Quality in budget planning and resource allocation for the GCP Quality department

Requirements

  • MS, or BS or similar in Natural Science
  • 15+ years of experience in a GCP Quality function or similar with proved leadership experience or aspiration to do so
  • Deep expertise in GCP processes and the European requirements
  • Demonstrated leadership in regulatory inspections and health authority interactions
  • Considered to be a Domain Expert within GCP by peers with a strong interest and ability to educate others
  • Experience as Lead Auditor within GCP is an advantage

About You

  • You bring precision and excellence to all that you do
  • You believe in our rooted-in-science approach to problem-solving
  • You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
  • You take pride in enabling the best work of others on the team
  • You can grapple with the unknown and be innovative
  • You have experience working in a fast-growing, dynamic company (or a strong desire to)
  • You work hard and are not afraid to have a little fun while you do so
  • To strive and thrive in a setting with multiple complex tasks and shifting priorities
  • Pro-active and open-minded, a dedicated team player with excellent oral and written communication skills

Locations

The role will be in Denmark or in the US. Genmab has a hybrid working model where minimum 60% is expected to be on site presence, combined with the option to work remotely two days per week on average.

Pay

The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is: DKK804.800,00---1.207.200,00. 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.

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