Kelly · 7 hours ago
Clinical Quality Assurance Specialist
United States
Contract
Remote
Senior Level
7+ years expKelly® Science & Clinical is seeking a Senior Clinical Quality Assurance Specialist - Inspection Readiness to join a leading global eye health company with a legacy of over 170 years. This role involves supporting global clinical investigator site inspection readiness for ophthalmology studies, engaging with investigator sites, and providing support during regulatory inspections.
OutsourcingProfessional Services
Hiring Manager
Cristina Weed, MBA
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
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
We’ve been helping organizations find the people they need longer than any other company in the world.
10001+ employees
H1B Sponsorship
Kelly has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (85)
2024 (76)
2023 (59)
2022 (74)
2021 (81)
2020 (65)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Chris Layden
Chief Executive Officer
N
Nicholas Zuhlke
Vice President, Controller, and Chief Accounting Officer
Recent News
Kelly Services, Inc.
2025-11-08
2025-11-08
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