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 an experienced Senior Manager for our Quality Operations department with particular strengths in proactive and preventative work.
Your scope of duties:
As Senior Manager Quality Operations, you set the tone in terms of recognizing and avoiding discrepancies in the production process. With an experienced hand, you fine tune change control, deviation management and in the CAPA processes. You know how to strictly comply with all of the relevant cGMP requirements and local procedures without skipping a beat.
The quality of our pharmaceutical products is always the top priority for your work. To keep it from hitting a false note, you continuously manage the CAPA program, maintain a constant overview of change control and documentation relating to deviations and are able to confidently evaluate and classify the influences of deviations in the production process. You are responsible for assessing and assuring the successful implementation of required measures for avoiding deviations.
Motivating and qualifying members also plays an important role in your management position within the Quality Operations team. Here, you make yourself available as a mentor and promote the development of the team to ensure utmost awareness regarding cGMP requirements. When necessary, you assist in quality-related activities, participating as a member of the investigation team as well as an SOP collaborator and approver.
You have a Bachelor‘s degree or higher in Biology, Chemistry, Engineering, Industrial Management, Operations, Quality or Manufacturing (other degrees in combination with relevant experience may be considered)
You have at least six years of relevant work experience in Quality Assurance
You have an extensive working knowledge of current federal, local and international regulations as well as a good understanding of cGMPs and industry standards
You possess a strong ethical foundation and are very familiar with compliance processes
You have profound knowledge and understanding of deviations, CAPAs and change controls
You know how to review and approve GMP related documents (i.e. SOPs, protocols, etc.)
You are an excellent leader who can manage multiple projects and tasks with a goal-oriented, yet flexible approach
You have good communication, interpersonal and training skills as well as the ability to establish collaborative relationships in both English and German
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.