• Define, implement, manage and review quality management, quality system and quality compliance activities within the project
• Ensure compliance with applicable GMP requirements, internal quality standards and Data Integrity principles throughout the implementation
• Identify and assess potential process and system weaknesses and risks and support the Quality Control laboratories in defining appropriate mitigation measures
• Support the implementation and qualification of system interfaces in close collaboration with validation experts and other project stakeholders
• Provide Quality oversight and guidance for the implementation strategy and related concepts
• Maintain a comprehensive overview of ongoing project activities from a Quality perspective
• Coordinate implementation activities across different functional areas and supporting teams
• Support project planning, documentation and tracking of Quality related activities and milestones
• Act as the central point of contact for Quality Assurance within the project
• Support internal and external audits and inspections as a project subject matter expert
• Take responsibility for the Change Control strategy, including coordination, implementation and follow up

• University degree in engineering, natural sciences, pharmacy or a comparable field, combined with relevant experience in Quality Assurance, Quality Control or pharmaceutical manufacturing within a GMP regulated environment
• Alternatively, several years of professional experience in a GMP regulated environment with demonstrated expertise in Quality Management or Compliance
• Experience with computerized systems, digital laboratory systems such as Empower or LabX, and Data Integrity
• Practical experience with LIMS implementation, laboratory software or Quality Control environments is highly desirable
• Strong communication, presentation and data visualization skills combined with a solution oriented mindset

Professional and Technical Skills

• Very good knowledge of pharmaceutical Quality Management Systems and relevant GMP regulations
• Strong understanding of laboratory processes and Quality Assurance requirements
• Experience with quality and compliance requirements for computerized systems
• Strong analytical and problem solving skills with a high level of attention to detail
• Experience in risk assessment, Change Control and implementation projects
• Knowledge of statistics and a strong affinity for data and analytical topics is an advantage

Personal Skills

• Excellent communication skills and confidence in working across different functions and stakeholder groups
• Strong coordination skills and the ability to drive topics independently
• Structured, proactive and solution oriented working style
• Analytical and holistic thinking

Languages

• Fluent German
• Very good English