Director of GCP Quality

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!

About R&D Quality

R&D Quality encompasses four teams GCLP/GLP Quality, PV Quality, Audit Calibration, Quality 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 include:

• 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

• 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

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