Quality Compliance 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 Pharmaceutical organization, based in Baden-Württemberg Germany.
My client, an international player in the health care industry, is currently looking for a Quality Director within its pharmaceutical branch. The company is located in Northern Baden-Württemberg, where it's producing mainly generic pharmaceuticals. The positions is to be filled immediately on a permanent basis.
ROLE DESCRIPTION
The position as Quality Compliance Director is crucial to the global Quality Management System ensuring compliant product quality as well as continuous improvement. You'll be responsible for cross-functional teams to optimize the quality compliance and remediations. Furthermore you'll act as company representative during inspections.
RESPONSIBILITIES
Lead of significant projects related to Compliance and Remediation.
Resposnibility CAPA and inspection readiness processes that are crucial to a standardized and sustained QMS.
Ensuring robust processes to maintain CAPA management and remediation support.
Develop and implement for a strategy ensuring CAPA management and remediation run according GMP regulations
Responsibility for implementing QMS requirements related to CAPA Management and Compliance Remediation Support
Provide leadership according regulatory GMP/GDP requirements
REQUIREMENTS
University degree in pharmacy, engineering or another relevant natural science.
Excellent understanding of quality and regulatory requirements for drugs and biologics
At least 10 years’ experience in the FDA and/or EU regulated pharmaceutical environment
Multiple years experience in a managing role within the Quality department of manufacturing environment
Very good knowledge to establish a compliant QMS in a drug and/or biologics manufacturing environment as well as strong project management skills
Ability to communicate effectively with all levels of the global organization as well as ability to lead and implement multiple projects simultaneously
Excellent English language skills (orally and written)
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.
