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.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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