Senior Clinical Quality Assurance Specialist jobs in United States
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Kelly Science, Engineering, Technology & Telecom · 14 hours ago

Senior Clinical Quality Assurance Specialist

positionUnited States
timeContract
remoteRemote
senioritySenior Level
date7+ years exp

Kelly Science & Clinical is seeking a Senior Clinical Quality Assurance Specialist – Inspection Readiness for a contract role with a client involved in global ophthalmology clinical trials. The role focuses on ensuring inspection readiness for clinical investigator sites, coaching staff, and providing support during regulatory inspections.

Staffing & Recruiting

Responsibilities

Lead inspection readiness activities for global clinical sites, including pre-inspection visits, readiness reviews, interview preparation, and document workflow coaching
Support/coach site staff in key clinical quality areas: informed consent, protocol compliance, data integrity (ALCOA+), safety documentation, investigational product/device accountability, and ophthalmology-specific risks
Serve as site-facing support during regulatory inspections (FDA BIMO and others), coordinating front/back room activities, managing document requests, and ensuring accurate responses during inspections
Conduct targeted site assessments/audits based on risk and provide evidence-based readiness reports
Collaborate with cross-functional teams to strengthen site oversight, support CAPA, identify risks, and drive continuous improvement

Qualification

Clinical research experienceGCP complianceInspection readinessOphthalmology experienceASQ Certified Quality AuditorFDA BIMO experienceCollaboration skillsIndependent work

Required

Bachelor's degree in life sciences or related field
7–12+ years in clinical research/quality assurance (focus on investigator site-facing GCP compliance + inspection readiness)
Experience directly supporting investigator sites through live regulatory inspections; FDA BIMO experience strongly preferred
Experience with pharma trials (IND/Phase 1–4) and medical device investigations (surgical/non-surgical)
Independent, collaborative, and able to travel up to 50% (domestic/international)

Preferred

Ophthalmology clinical trial experience
ASQ Certified Quality Auditor (CQA) or equivalent
Experience with inspection readiness tools and supporting inspections across multiple regions

Company

Kelly Science, Engineering, Technology & Telecom

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Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
dateFounded in 1946
location
Troy, Michigan, USA
people-size5001-10000 employees
web-link
https://set.kellyservices.us/

Funding

Current Stage
Late Stage

Leadership Team

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Linda Stuit
Senior Vice President, Engineering Specialty
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