Responsibilities: Govern owned QMS applications, including harmonization of processes across sites. Responsible for requirements authoring & ongoing maintenance by leading & facilitating meetings/workshops with Site Process Owners & Key Users (Business SMEs). Approve validation deliverables including initial implementation & operational changes.
Requirements: Bachelor's in Comp Sci, Engineering, or related field & 5 yrs experience implementing & maintaining regulated systems. Experience must include 5 yrs each of following: project management; development of user procedures; and SaaS (Software as a Service Solution)/cloud solutions. Experience must include one year each of the following: TrackWise Digital, ComplianceWire, and Veeva; system testing in a regulated industry; quality systems processes in commercial/clinical pharma/healthcare facility; US FDA, ICH guidelines, and European regulatory requirements; GAMP; and development of CBT (computer-based training) modules. Experience may be gained concurrently.
Send resume via email to [email protected] or mail to Alkermes, Inc., c/o Shawna Weidman, 900 Winter Street, Waltham, MA 02451-1420. Please reference Quality Systems Lead.
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