Clinical Quality Specialist

Talent Groups

Hybrid Details: 3-5 days/week onsite

Duration Details: 6 months to start

Job Description
The Clinical Quality Specialist, under the direction of the CQA management team, will be responsible to support Clinical Quality and their operations in ensuring compliance of client clinical studies, vendor management, and inspection readiness according to approved procedures, global regulations and ICH, GxP requirements.

Position Details:

Support the processing of audit reports, change controls, deviation, and audit plans
Support CQA team in the coordination, investigation, escalation, and resolution of issues identified during Clinical Quality Operations
Support scheduling of audits with internal and external stakeholders
Collect and generate metrics for Clinical Quality Operations.
Assist in gathering requirements for improvements and ongoing maintenance by participating in meeting/workshops with Site Process Owners and business SMEs
Participate in CQA meetings and the additional forums including but not limited to Inspection Readiness and Regulatory Inspections
Assist Clinical Quality in supporting internal and external stakeholders in the processing of deviations, Quality Investigations, and audits
Follow-up on requests, issues, and projects and report statuses to manager and CQA team
Support the management and maintenance of the Clinical Quality Vendor Management database.
Provide CQA support through training management and onboarding of new employees.

Academic/Technical 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 2-5 years of experience in commercial pharma, CRO, clinical pharma, or healthcare facility
Proficient in MS Word, Excel, and Quality System processes. Experience with Veeva, TrackWise, and ComplianceWire is a plus.
Understanding and working knowledge of US FDA and European regulatory requirements. Knowledge of Regulatory Compliance, ICH Guidelines, GxP standards

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Vacancy posted 5 days ago

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