- 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
- 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
- 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
- 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
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Associate Director, QA GMP - Copenhagen, Danmark - Genmab
Beskrivelse
The Role
& DepartmentAt 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
Additionally, perform the following tasks as a part of the GMP QA Team
Requirements
About You
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.
