Associate Director, GCP & PV QA

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!

The Role

We are looking for a highly motivated QA Associate Director with at least 10 years of experience within GCP. You are likely already an experienced lead auditor with the capabilities to train other auditors as well as acting as a GCP Advisor. Furthermore, you have participated in FDA, EMA and PMDA inspections either in a leading or a supporting role.

As QA Associate Director you will have in-depth and strong scientific expertise within quality assurance and all regulatory requirements related to clinical development, especially FDA, EMA and PMDA. It will be an additional asset if you have knowledge within regulatory requirements of the NMPA. You will have strong analytical skills, high quality standards, and attention to detail as well as the ability to apply these qualities into a strategic context that enables you to identify solutions within agreed deadlines.

You will be working in a global team with QA colleagues located in the US, the Netherlands, Japan and Denmark. Furthermore, you will be part of a strong cross-functional collaboration throughout the company.

Key responsibilities include:

• You will plan, conduct, report and follow up on quality audits within the GCP regulated areas.

• Lead or/and support GCP inspection activities in connection with FDA, EMA or PMDA inspections

• Mentor on-boarding QA colleagues as well as experienced Lead auditors to increase the competency level across the global QA GCP & PV team.

• You will develop and maintain the audit strategies in collaboration with the Team Lead

• 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.

• Lead quality improvement initiatives to enhance processes and procedures.

• Develop and deliver training programs for internal teams and external partners, as applicable.

• 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.

Requirements:

• MSc in Natural Science or similar and at least 10 years of profound experience within GCP.

• Experienced Lead Auditor within GCP

• Practical proficiency in the use and understanding of Veeva Vault QMS

• Experience with the due diligence process and qualification of new vendors or services

• Considered to be a Domain Expert within GCP by peers with a strong interest and ability to educate others

About You

• You are genuinely passionate about our purpose

• 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…