Quality Compliance SpecialistVirtualVocations • Bridgeport, Connecticut, United States
Quality Compliance Specialist
VirtualVocations • Bridgeport, Connecticut, United States
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A company is looking for a Quality Compliance Specialist to oversee clinical trial delivery quality systems and ensure compliance with regulations.
Key Responsibilities
Lead the clinical trial delivery system inspection readiness program and engage with relevant functions to ensure accountability and transparency
Host GCP inspections and manage inspection response activities, ensuring timely and adequate responses
Act as Subject Matter Expert on Clinical Quality Compliance activities, leading complex quality investigations and managing CAPA development
Required Qualifications
BSc in a scientific or allied health / medical field (or equivalent degree)
Minimum of 7 years of relevant experience in the pharmaceutical industry, including at least 3 years in GCP Quality / Compliance
Advanced knowledge of pharmaceutical development and GCP / GVP regulations
Experience in developing and implementing clinical audit programs and leading regulatory inspections
Skilled in managing global, cross-functional projects
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Compliance Specialist • Bridgeport, Connecticut, United States
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