QA Director
Location: GermanySIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Biotechnology organization, based in Hamburg Germany.
My client, an innovative and strongly growing CRO for the biotech industry, is currently looking for a QA Director. The company focusses on laboratory services to support the development of biologics. This position is located in Hamburg and is to be filled immediately.
ROLE DESCRIPTION
As QA Director you'll manage the quality department and are responsible for the European Quality Management System.
RESPONSIBILITIES
Conduct periodic reviews of the QMS and implement CAPAs
Lead the European QA to to ensure a compliant QMS according regulatory and company requirements
Oversee audits as well as the generation of QA SOPs
Provide regulatory input for other department SOPs
Be the contact person for Government Agency Inspections.
Analyze and communicate assessments of significant compliance risk information to the Global QA department and other Executive Management.
REQUIREMENTS
University degree in a science field
Extensive knowledge of GLP or GCLP/GCP, global regulations and industry standards
At least 6 years working in a GLP or GCLP/GCP regulated environment with several years proven management experience.
Audit experience is required
Very good English and German language skills (oral and written)
Ability to travel internationally (at least 25%).
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.