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.

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

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 also being directly vested in the commercialization of the company's products, we are now looking to further strengthen the QA Commercial & Life Cycle team located in the United States and Denmark. In this position, Quality Assurance (QA) Associate Director, you will set the quality direction for Genmab's Commercial Supply Chain in the US market.

As GMP QA Associate Director you will be an important part of the global GMP QA team to ensure compliance with industry standards and regulations. This position will be in the US reporting to the Director of QA GMP, Commercial & Lifecycle (located in Denmark). The QA GMP team at Genmab currently employs 25 people located in Denmark and US. Our new colleague will report to Team Lead QA GMP Commercial & Lifecycle. The QA Department has a total of 51 employees supporting GxP activities and located in Denmark, the US and Japan.

Responsibilities & Task
Maintaining and continuously improving Genmab's Pharmaceutical Quality System to ensure compliance with local US regulations.
Gaining and maintaining knowledge on new/updated GMP/GDP-regulations and guidelines.
Handling of Deviations, CAPAs and Change Control in compliance with Genmab SOPs and applicable regulatory requirements.
Handling and improving the Product Complaint intake and investigation in compliance with Genmab SOPs and applicable regulatory requirements.
Reviewing and authoring of QMS SOPs, Work Instructions and other documents, as needed.
Supporting Quality Management Review and Annual Product Review
Assisting Lot Distribution Reporting and Drug Amount Reporting for FDA submission
Performing QA activities in relation to US market release in close cooperation with the global QA GMP team, Genmab's CMOs, contract acceptors and Partners.
Providing product dispositions and releases to US commercial market.
Providing QA oversight of contractors/vendors in relation to outsourced GMP/GDP activities including Audits, Vendor Risk Evaluations, and review of Quality Agreements.
Representing QA GMP in project groups to advise on GMP and GDP compliance.
QA Representative in internal audits and regulatory inspections performed by various Health Authorities.
Contacting with local authorities including the FDA for local authorization maintenance and reporting such as BPDR, Drug Shortage and Recall.
Ensuring that initial and continuous GMP/GDP training programs are implemented and maintained.


Requirements
Bachelor/MSc degree in a relevant life science subject.
10 years' experience within the pharmaceutical industry within QA GMP/GDP.
Lead auditor experience.
Previous FDA inspection experience required
Excellent interpersonal skills, problem-solving skills, communication skills in English, and a collaborative mindset.
As a person you enjoy a fast-paced and changing environment.
You are results and goal-oriented and committed to contributing to the overall success of Genmab.
Ability to travel 10-20%


For US based candidates, the proposed salary band for this position is as follows:

$138,750.00---$231,250.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.

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...

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity