Associate Director, Quality Assurance

Associate Director, Quality Assurance

Genmab

Copenhagen, Denmark

The Role

The global quality team of Genmab is growing and we are looking for a new colleague in Quality & Compliance Systems. The team is part of our Global Quality Assurance function, and we work across GxP areas with maintenance and optimization of Quality owned processes and systems. This role also provides compliance support for GLP, GCP, GVP, GMP, GDP and IT areas across all Genmab sites and monitors the compliance state of Genmab.

We are looking for an individual who is excited to join a forward-thinking team dedicated to continuously improving and simplifying quality processes and systems. This role offers the chance to make a real impact - not just by supporting essential day-to-day activities, but by contributing to strategic initiatives that shape how quality is managed across the organization.

The main system we support is the Quality Management System that is the Veeva Quality Vault system.

Responsibilities

• Training Subject Matter Expert. You will be the QA Training SME supporting the set up and maintenance of training matrixes and adherence to the requirements and best practices related to training in global QA. Also work across Genmab organizations to monitor and support training activities and strategies;
• Drive continuous improvements for the quality system. Genmab has performed a Continuous Improvement Innovation (CQI) exercise with Veeva and you will be the driver of establishing Roadmap and execute improvements to the system. You will be part of the Vault Governance with significant influence on future configuration of the system;
• Genmab is expanding into new markets in Europe and rest of the world and this challenges our existing procedures hierarchy. You will review, evaluate and implement revised hierarchy as needed. Seek to deploy helping tools from emerging technologies (e.g. AI) to improve in the way Genmab is handling procedure lifecycle;
• Perform compliance performance monitoring. You will generate reports and dashboards as part of the compliance monitoring for the organization;
• General QA work with update of procedures, approval of quality events, participate in inspections etc.

Requirements

• Master’s degree or equivalent and 6+ years of industry related experience within the pharmaceutical or biotech industry, preferably in a global setting;
• Excellent knowledge and understanding of the regulatory requirements of minimum one of the GxP areas (GLP, GCP, GVP, GMP, GDP, IT);
• Extensive knowledge and understanding of quality management processes related to documentation, governance and quality system oversight;
• Demonstrated ability to lead cross-functional improvement projects;
• Strong expertise in training management systems and practices;
• Familiarity with procedure management and document hierarchy in a regulated environment;
• Interest or hands-on experience in leveraging emerging technologies to optimize quality system processes;
• Analytical mindset and a proactive, solution-oriented approach;
• Ability to work successfully under pressure in a fast-paced environment and with tight timelines;
• Knowledge of Veeva Vault system will be a benefit;
• Excellent written and verbal communication skills in English.

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!

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