Associate Director, QA GMP

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role & Department
At Genmab we are now looking to further strengthen the Late Stage Development QA Team located in Denmark. In this position, the Quality Assurance (QA) Associate Director will set the quality direction for Genmab’s Late-Stage Development products.

As GMP QA Associate Director you will be an important part of the global GMP QA team to ensure compliance to industry standards and regulations. This position will be located in DK, reporting to the Director of QA GMP Late-Stage Development (temporarily located in the US). The role has no direct reports. The Global QA Department is composed of more than 50 employees working in GXP and are based in Denmark, the Netherlands, the US and Japan.

This role is located in Copenhagen, Denmark and is hybrid.

Key responsibilities

• Act as Delegated QP for the certification and release of IMP for clinical trials
• Act as deputy RP for GDP processes and issues
• Contributing to Quality Oversight of CMOs by auditing GMP and GDP CMOs, negotiating Quality Agreements, and performing vendor evaluations
• Handling Product Complaints
• Maintain training programs for GDP and GMP, train stakeholders in relevant GDP and GMP topics

Additionally, perform the following tasks as a part of the GMP QA Team

• Maintaining and continuously improving Genmab’s Pharmaceutical Quality System (PQS) to ensure compliance with GMP and GDP regulations
• Reviewing and authoring of PQS SOPs, Work Instructions and documents
• Gaining and maintaining knowledge on new/updated GMP/GDP-regulations and guidelines
• Representing QA GMP in project groups to advise on GMP and GDP compliance
• Promote collaborative relations with relevant internal stakeholders, partners, and CMOs
• Handling of Deviations, CAPAs and Change Control in compliance with Genmab SOPs and applicable regulatory requirements
• Participating in internal audits and audits and regulatory inspections performed by Partners, Health Authorities

Requirements

• You hold a MSc degree or equivalent in a relevant life science subject
• You have +10 years of experience from the pharmaceutical industry within QA preferably within biologics and/or sterile products and GDP
• Experience within development products for clinical trials in late development phase including process validation is an advantage
• Outsourcing experience, lead auditor experience is an advantage
• Experience working in an EDMS system
• You have excellent communication skills in English, and a collaborative mindset
• As a person you enjoy an ambitious and changing environment
• You are result and goal oriented and committed to contributing to the overall success of Genmab

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to 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 leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed 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 guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website https://www.genmab.com/privacy.

Location: Copenhagen - Carl Jacobsens Vej 30