Associate Director, GCP & PV QA

At Genmab we are dedicated to building extranotordinary 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 organizations 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 while you do so!

Locations

Genmab maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.

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 Genmabs 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 and follow us on LinkedIn and X.

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