Senior Manager Quality Assurance GDP

Job description

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! Role With a clear strategy of becoming an integrated end-to-end biotech innovation powerhouse, Genmab is directly involved in the commercialization of our products. To further strengthen the Quality Assurance Commercial & Lifecycle team located in Denmark and the United States, we are looking for a Senior Manager, Quality Assurance (QA) to join our Good Distribution Practice (GDP) team in Denmark. As Senior Manager, QA - GDP, you will play an important role in ensuring quality and compliance across Genmab’s global commercial distribution network. You will have a broad and hands-on role covering storage and distribution activities, vendor oversight and cross-functional projects, working closely with international vendors and partners as well as stakeholders across QA, Supply Chain and Commercial Operations. Auditing is a significant part of the role, and you will conduct GxP audits of external vendors and partners across our global network. The role requires approximately 50% international travel to vendors and partners, primarily in connection with GxP audits. We are looking for an experienced QA professional who is comfortable taking ownership and navigating new or unfamiliar areas. As a Senior Manager, you will also act as a subject matter resource within your areas of responsibility, providing quality guidance and advice to stakeholders and contributing to compliant and risk-based decision-making. This is an individual contributor role at Senior Manager level. The position is based in Denmark and reports to the Director of QA GMP, Commercial & Lifecycle - Storage and Distribution. Responsibilities Plan and conduct GxP audits of external vendors and partners and contribute to audit planning, follow-up and continuous improvement based on audit observations and trends. Take ownership of vendor oversight activities, including vendor risk evaluations, quality agreements and follow-up on the performance and compliance of GDP vendors. Independently manage operational GDP quality activities, including external notifications, change controls, deviations and other quality issues involving external partners. Participate in and support recall operations for the EU market in collaboration with the global QA GMP team and external partners. Contribute to shipping lane validation/qualification and perform GDP risk assessments related to storage, transportation and supply chain operations. Contribute to the implementation and continuous improvement of quality systems, SOPs and work instructions. Represent QA GDP in cross-functional and global projects, taking ownership of QA deliverables within assigned areas. Perform shipment release and support EU serialization activities. Support implementation and maintenance of GDP training. Participate in regulatory inspections and internal audits. Maintain knowledge of new and updated GDP regulations and guidelines and translate relevant requirements into practice. Collaborate closely with Supply Chain, Commercial Operations and other stakeholders to ensure compliant distribution practices. Handle and contribute to continuous improvement of Product Complaint intake and investigations. Take on new quality topics and assignments as business needs evolve, independently building the knowledge and stakeholder network needed to bring activities forward. Requirements Bachelor’s or master’s degree in science or related field. You have 8+ years of experience within the pharmaceutical or biotech industry, with significant experience within Quality Assurance and GxP. Experience within GDP and commercial distribution is preferred but not required. You have solid experience conducting GxP audits and are comfortable acting as an auditor. Audit experience is a requirement for this position. You are proactive, curious and comfortable taking ownership of assignments, independently navigating new or unfamiliar areas and finding solutions where the way forward is not predefined. You have strong interpersonal and problem-solving skills and can establish effective relationships across functions, geographies and with external partners. You communicate confidently in English and are comfortable asking questions, challenging constructively and making quality decisions within your area of responsibility. You must already be based in Denmark at the time of application, and you are willing to travel approximately 50% of the time across Europe, the United States, and the rest of the world on a long-term basis. 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 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). The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is: DKK607.920,00---911.880,00 The final salary offer will depend on several factors, including your skills, qualifications, and experience. In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to: Pension Health insurance and wellness benefits Paid time off Employee support programs Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process. 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, 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 international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X . 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 Job Applicant Privacy Notice (genmab.com) .