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Key Responsibilities:
- Maintain a complete inventory of electronic GxP systems, ensuring proper classification, validation status, and ownership.
- Execute system validation activities including IQ/OQ/PQ documentation and test execution across the system lifecycle.
- Partner with IT and system owners to ensure controlled access, data protection, and change management aligned with GxP risk profile.
Qualifications:
- Bachelor’s or Master’s degree in a scientific, technical, or information systems discipline with 6+ years of relevant experience.
- Demonstrated hands-on experience administering electronic GxP systems such as MasterControl, Veeva, TrackWise, or Documentum.
- Strong proficiency with Microsoft 365 and system reporting tools, with proven experience supporting validated system lifecycles.
Work Environment:
- This is a remote opportunity with occasional travel estimated at less than 10%.
- The role requires comfort operating as an individual contributor in a regulated environment with clear accountability for system execution.
- A detail-oriented, execution-focused mindset is essential for managing multiple system activities independently.
Kaléo
Kaléo is a global leader in drug‑delivery device technology and auto‑injector innovation. The company provides millions of patients, government partners, and emergency responders with security and peace of mind, operating as a focused, execution-driven organization.