Director Global Product Development and External Supply Operations Quality
Director Global Product Development and External Supply Operations Quality
Stada
Bad Vilbel, Germany
Your responsibilities:
- Coordination and participation of ESO Reviews with Strategic CMOs;
- Development of cross functional ESO Quality infrastructure to ensure holistic CMO management;
- Continuously improve the performance of the ESO organization, to achieve global targets;
- Identifies opportunities for continuous improvement of processes and organizational effectiveness within Key Strategic Contract Manufacturers;
- Oversees Competent Authority Preparation activities and supports CMOs through authority inspections;
- Supports proper selection, qualification, and approval of service providers for Drug Product Formulation and Drug Substance developments;
- Reviews Development contracts with respect to Quality information and ensures QTA preparation;
- Supports evaluation of deviations and corresponding investigations of validation batches and stability studies, occurred during development, and produced internally or at CMOs;
- Monitors current and upcoming pharmaceutical legislations (e.g. but not limited to AMG, cGMP, AMWHV, BtMG, ICH);
- Ensures batch release of Clinical supplies manufactured at STADA sites or CMOs;
- Assessment of product/portfolio/development/manufacturing site compliance, summary of results in overall due diligence report.
Your qualification:
- University degree, diploma, in the area of Science;
- 5+ years in a similar role in the Pharmaceutical/Medical Device Industry;
- Appropriate competence and experience as well as strong knowledge of and training in global Good Manufacturing Practices (GMP), Food Supplements, Device regulations Cosmetics, Household goods;
- Experience of the development and maintenance of a quality management system at a local and regional level;
- Has experience as Qualified Person for IMPs;
- Good Communication skills;
- Strong MS-Office and Databases-skills;
- Fluent in English, any other European language would be a plus.
More Job Searches
Germany Manager and Executive Manufacturing and Logistics Medical Devices Quality Assurance Stada
