Provide general support in assigned Quality projects and activities
Contribute to the design, implementation and/or execution of Quality processes and Quality-related IT and AI solutions
Work on quality event process/solution design, document and data management
Actively participate in projects and continuous quality improvement initiatives and deliver timely, appropriate quality outcomes
Attend conferences and perform other operational activities as needed
Lead Phase 0 workshops to assess current state and define future-state QMS processes
Design scalable, GxP- and PQS-compliant QMS frameworks and advise on standardization, tool selection, and digital transformation
Implement and support GxP-compliant third-party/supplier quality processes including qualification, audits, performance monitoring, and risk assessments
Integrate supplier quality workflows into enterprise QMS platforms
Support deployment of data analytics and AI/ML use cases (predictive quality, intelligent document processing, risk-based deviation analysis)
Collaborate with data science and IT teams to embed analytics into QMS platforms
Facilitate workshops with cross-functional stakeholders to gather requirements and define solution scope
Translate business needs into functional specifications and system configurations
Requirements
Bachelor’s or master’s degree in a technical, scientific, or medical/clinical discipline
Strong understanding of GxP and global regulatory frameworks and standards such as FDA, EMA, MHRA and ISO 9001
Minimum of 5 years “hands-on” quality expertise
Previous experience with Quality IT systems preferred (e.g., Veeva Quality Vault, TrackWise, TrackWise Digital, ETQ Reliance, MasterControl)
Experience with quality processes such as deviations, CAPAs, change controls, risk management, vendor/supplier quality
Experience designing or improving quality processes (e.g., creating SOPs)
Experience training staff and/or change management experience
Experience working with a wide range of technically and culturally diverse people
Excellent communication, facilitation, and stakeholder management skills
Strong communication skills in English, both verbal and written
Demonstrated ability to handle multiple projects/deadlines
Great focus and attention to detail
Ability to work both independently and within a team
Adaptable to new responsibilities
Benefits
Health insurance
Remote work friendliness
Ongoing learning and development
Flexible schedules to fit your work to your routine
Contributions to physical, social, and emotional health
Home office setup with laptop and other electronic devices
The chance to help make a difference for patients around the world
Recognition as a Great Place To Work in multiple countries
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