Quality System Manager (m/f/d).

Job ID: 10860

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Discipline
Quality/Production
Type of employment
Project Consulting
Responsibilities
  • Build assigned Quality System Elements according to industry best practice
  • Identify compliance risks in manufacturing processes and procedures and lead the resolution for assigned QS Elements
  • Ensure that Deviation Investigations and Corrective Action/Preventive Action (CAPA) plans are implemented to resolve these risks
  • Ensure that processes are appropriate and activities performed in a timely manner
  • Review and approve relevant changes to these systems and report about the performance of these systems
  • Participate in and provide quality leadership for routine Operations Meetings to monitor KPIs
  • Mentor, guide and train Manufacturing Operations employees on cGMP and the processes of the dedicated specification
  • Provide support to Regulatory Compliance during internal and external audits and inspections
  • Maintain the assigned Quality System elements compliant with the Quality System and with the applicable international regulations
  • Lead continuous upgrade of Quality Management System elements within the Biologics network
Requirements
  • Master’s degree in life science, engineering or equivalent
  • 8+ years of experience in Quality or Manufacturing of of Biologics
  • 5+ years of experience in managing QMS elements in a regulated evironment is required
  • Extensive knowledge of cGMP
  • Proven track record of resolving complex compliance issues and delivering on business results
  • Fluent both in German and English
  • LEAN/Six Sigma certification preferred
Benefits
  • An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
  • An attractive, market-oriented salary
  • An individual and well-structured introduction and training of new employees.
  • As a globally successful
Region
Mitte