Hybrid Senior Quality Consultant/Manager

Posted last month

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About the role

  • 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

Job title

Senior Quality Consultant/Manager

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Tech skills

Location requirements

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