1+ years’ experience as a skilled practitioner in GMP Change Control and familiarity with QMS tools.
2+ years of relevant change control experience, preferably in a GxP environment.
Proficiency in relevant technology such as Veeva QMS, Oracle Agile QMS, Trackwise, Smartsheet, MS Project, Visio, PowerPoint and MS Office for efficient project administration and implementation.
Experience in life sciences industry such as cell/gene therapy, pharmaceutical, biotech, or medical devices is a plus.
Demonstrated mastery of change control management processes, procedures and methodology.
Independently motivated and detail oriented with excellent communication skills.
Excellent organizational skills and ability to multi-task in a exciting environment.
Collaborative individual, able to influence without authority and engage senior leaders and functional partners proactively.
Demonstrates respect, focuses on delivering value, and embraces learning and continual improvement