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™ (currently undergoing clinical trials in the US). We are seeking a Senior QA Manager Release to successfully bring our products to the market.
Your scope of duties:
You successfully incorporate your experience into the release of batches as a QP (Qualified Person). Here, you work in strict compliance with the German Drug Law (§15 AMG) while also considering any applicable international and national guidelines (i.e. AMG, AMWVH).
With utmost accuracy, you examine change controls, deviations and OOS investigations. In regards to deviations, you also decide whether they could have a negative impact on our high pharmaceutical quality standards in the release process. The issue, review and approval of SOPs related to your position is among your responsibilities as are product quality reviews. You constantly look for ways to optimize your processes and tasks.
As Senior QA Manager Release, you lead a team currently consisting of 3 members. They count on your leadership to keep them on a constant path of progress. You help them maintain the highest quality of work while motivating them – both as a team and individually.
You have a university degree in Life Sciences (Pharmaceutics, Biology, Microbiology, etc.) as well as at least 5 years of experience in quality operations in a release group
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 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 are a qualified person and can manage multiple projects and tasks with a goal-oriented, yet flexible approach
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.