Quality 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 and Pharmaceutical organization, based in Hamburg Germany.
Our client is a company providing their analytical services for clinical phase I to IV projects including:
- Assay development
- Validation
- Sample analysis
- Drug release testing
ROLE DESCRIPTION
The lab is under GLP/GCP/GMP
RESPONSIBILITIES
- Report to Global VP of QA
- Manage and enhance QMS and CAPA responsibility
- Lead the EU Quality Organization
- Manage audits according to SOPs and regulatory requirements
- (Re)write SOPs for QA and implement regulatory
- Hosting external audits / agency inspections
- Communicate and analyse risks to VP QA and Site Management
REQUIREMENTS
- Experience in QA Environment ideally in GCP / GLP / GMP
- Experience with People Management
- Experience dealing with regulatory authorities
- Travel up to 25%
- Fluency in English is required.
- Fluency in German is required.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.