Location: Hybrid - Waltham, MA (Onsite Tues, Wed, Thurs)
Responsibilities:
Assist in the governance of Quality System applications, including harmonization of processes across sites
Assist in gathering requirements for improvements and ongoing maintenance by participating in meetings/workshops with Site Process Owners and business SMEs
Participate in additional user forums for gathering ongoing requirements and prioritization and triage issues
Follow-up on requests, issues, and projects and report statuses to manager/ working teams
Initiate and manage change controls, with associated documentation requirements, to completion
Ensure the system is maintained in a validated state by participating in periodic user access reviews, ongoing change management, business administration, and deviations/CAPAs associated with Quality Systems
Support validation activities as requested; this includes but is not limited to requirements gathering, validation planning, design qualification, authoring test plans, and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary reports
Qualifications:
Bachelor's degree or higher in relevant computer/technical/quality/scientific discipline, preferably multi-disciplinary with a strong technical and quality background
Minimum of 3-6 years of experience in a high-volume commercial/clinical pharma/healthcare facility
Proficient in MS Word, Excel, and Quality System processes. Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus.
Understanding and working knowledge of US FDA and European regulatory requirements and GMP, and the ability to determine phase-appropriate requirements
Knowledge of Regulatory Compliance and ICH Guidelines