CMC Complaints & Returns
Genmab
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
With a clear strategy of becoming an integrated end-to-end biotech innovation powerhouse, Genmab recently started to market and sell their own products within cancer treatment. Expanding its focus to being directly vested in the commercialization of the company’s products, we are now looking to further strengthen the Commercial Supply Chain team in Denmark.
Genmab is looking for a Manager, Complaints and Product Returns, to join the Commercial Supply Chain team. In this new role you will work to support and strengthen the further commercialization of Genmab’s portfolio. You will play a key role in establishing the processes for managing and resolving customer complaints and product returns while ensuring regulatory compliance and product safety.
The Senior Manager, 3PL Warehouse and Logistics Europe, will become a part of the Commercial Supply Chain department. A department that currently employs 18 people in Denmark and US.
Key Responsibilities Include
Serve as the primary point of contact for complaints or returns and oversee the handling, resolution, and prevention.
Ensure regulatory compliance and product safety throughout European supply chain.
Prepare and submit regulatory filings for adverse events or significant complaints, as required and analyze complaint trends to identify recurring issues and areas for improvement.
Own and maintain the related standard operating procedures (SOPs) regarding complaints and returns.
Oversee the end-to-end complaint handling process, including logging, investigation, root cause analysis, and closure of complaints.
Coordinate the complaint handling between internal Genmab partners as well as external partners such as 3PL and regulatory authorities, while ensuring that processes are aligned with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP).
Manage potential recalls according to Genmab's procedures. Prepare data for Quality Management Reporting and Annual Product Quality Review.
Develop and implement processes for handling product returns, including product inspection, documentation, and disposition.
Collaborate with logistics, quality and warehouse teams to ensure the proper handling of returned goods.
Maintain accurate records of returns and ensure compliance with Good Distribution Practices (GDP). Monitor return trends and provide recommendations to reduce product returns.
Work with Quality Assurance to maintain GxP compliance throughout the warehouse and distribution network. This includes shipping validations, quality events handling – support investigations of quality events, external notifications and complaints, determine root causes, implement CAPAs and drive closure.
Requirements
A Bachelor in related field from either University or Technical University.
At least 3 years of bio-pharmaceutical industry experience and working in GxP environment.
Experience in pharma complaint and return management and regulatory compliance.
Experience working with corporate partners and alliance management.
Fluently in English, both verbal and written.
Experience with process handling and SOP management in GxP environment.
This role is based in Copenhagen, Denmark, and is hybrid.
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.
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