Quality Systems Specialist (m/f)

REFERENZNUMMER:

356615/11

IHRE AUFGABEN:

-Serve as IMP Quality Systems SME to collaboratively set direction, implementation and enhancement of GMP phase adapted PQS and Global quality business processes with sufficient flexibility for operational and development needs
-Lead, facilitate and/or manage global IMP Quality non-molecule PPM projects
-Interpret global, company-wide GMP systems/business processes to apply to the development pipeline
-Interpret global regulatory requirements relative to the global clinical quality system development and maintenance
-Collaborate on development of global documents consistent with the overall global document master plan; address and resolve identified issues during the global IMP review
-Maintain awareness of new regulations (e.g. ICH) and monitor emerging regulatory trends to assess impact on the clinical quality systems and the business and evaluate impact to established Quality Systems

IHRE QUALIFIKATIONEN:

-B.S. or B.A. degree and profound business and/or technical experience in the pharmaceutical or biopharmaceutical industry preferably in clinical (IMP) development. Advanced degree desirable
-Current working knowledge of cGMPs, ICH guidances, and regulatory and industry technical standards relative to clinical (IMP) development
-Previous experience with development of quality standards and processes
-Proven track record of successfully planning, implementing, and tracking of global/highly complex projects on time and within budget
-German and English proficiency required

WEITERE QUALIFIKATIONEN:

Quality manager