Head of Global Quality Assurance
Strengthen and Build Up Global Quality Assurance in an Ambitious Biotech Company
Genmab is in the process of expanding its clinical pipeline with more drug candidates, and at the same time, Genmab is preparing to launch its own products.
As Head of Global Quality Assurance at Genmab you will lead the QA Team, which is responsible for all GxP related activities. Furthermore, you will collaborate with and support all functions across the organization with the overall goal to develop new and innovative medicines for patients.
With direct report to SVP, Head of Operations R&D; overall responsibility for QA Compliance lies with EVP, Chief Development Officer.
Your main responsibilites are:
- GxP compliance strategy & quality strategy, implementation & surveillance, pre and post approval
- GxP systems and policies
- Gap & risk assessment and remidiation planning
- Technical/Quality Agreements
- Inspection readiness
- GMP & GDP systems implementation and maintenance
- CMO responsibility regarding Compliance & Quality
- QP and release responsibility
- Quality metric implementation and follow up
- Product Quality review incl. verification, qualification, and validation strategy for review/approval
- QA oversight for Genmab and CMOs
- Continuous quality improvement
- Balance quality, delivery, and cost
- Setting the standard and bar at the right level from early development to and through commercialization
- GLP and GCP oversight
Your qualifications are minimum 10 – 15 years of Quality Assurance Management experience within the life science industry, both in Europe, USA, and Japan on both a strategic and operational level. Minimum 5 years of experience from manufacturing or QC. You must fulfill the qualifications to become Genmab QP and have a solid background and experience in working with external partners (CROs, CMOs and consultants). You have demonstrated results at both a strategic and hands on level in managing pre and post approval QA relationships, and you have experience in working with FDA and other agencies on a global scale. Managerial experience from a global QA position and managerial line or matrix experience from the pharma industry is required.
You have excellent English communication skills, both written and spoken, and you are an advanced user of MS Offfice, Access, and other relevant IT tools or systems.
You have a Master’s Degree preferably in Pharmacy, Engineering or are a Doctor of Veterinary Medicine.
As a person, you are comfortable with a risk-based approach to decision-making and comfortable in a dynamic environment in which priorities and drives can quickly change. You are able to communicate clearly toward upper management, are quality driven, and robust.
Genmab offers a challenging position within QA where the right candidate will get the opportunity to work with highly specialized people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients. Genmab is an organization with a short chain of command, and as Head of Global Quality Assurance, you will have the opportunity to influence your own work as well as your personal and professional development.
Travelling: 30 days per year
Domicile: Preferred location is Copenhagen
For more details about the job or the company, please contact Partner Jørn Duhn, Unique Human Capital on M +45 21 75 19 25. All applications must be in English and are treated confidentially.