QA Manager Vendor Management (m/f)
Are you looking for a change of pace? Then hit the ground running with Dynavax!
Over the past 30 years, Dynavax has proven its innovative potential in developing and manufacturing biopharmaceuticals. Our production processes follow the highest quality standards. This is true for all our products, including our new hepatitis B vaccine HEPLISAV-B (currently undergoing clinical trials in the US). We are looking for an experienced QA Manager to maintain this level of quality in our Vendor Management department.
Your Scope of Duties:
You will ensure full compliance with our quality system for suppliers as well as our SOPs, which you may revise or create. You will also proactively develop new elements for the quality system.
The development of a sophisticated vendor qualification system will be a major focus of your work. Your tools here include internal and external audits, which you can carry out independently. You will summarize your results in writing and, where necessary, perform follow-ups for open items. Developing and leading GxP training modules are likewise among your responsibilities.
Other tasks include assessing and maintaining the document control system, providing support on all regulatory inspections / audits, providing quality assistance to other departments and managing company policies that affect units and sub-units.
To successfully achieve the objectives of your position, business trips will account for about 20% of your working time. You will report directly to the Senior Manager Quality Systems.
- You have a university degree in the Life Sciences (preferably Biology, Microbiology, etc.) as well as at least 5 years work experience in the biotechnology or pharmaceutical industry
- You have extensive knowledge of FDA and EU regulatory requirements for biologics and pharmaceuticals as well as a successful track record in improving and maintaining QA operations
- You have experience with regulatory agencies regarding the product approval process
- You have GMP knowledge and a proven ability in creating standards to support QA systems
- You have good communication, interpersonal and training skills as well as the ability to establish collaborative relationships in both English and German
- You can manage multiple projects and tasks with a goal-oriented, yet flexible approach
- You are also authentic, analytical and a problem solver
Are you ready to work in a challenging, but also dynamic and growing environment?
Then submit your application and make a difference in a position that gives you room to grow. We offer a competitive compensation package including benefits, a flat hierarchy and many opportunities for professional development. We look forward to hearing from you.
Please submit your application online.