Clinical Quality Compliance SpecialistVirtualVocations • Redding, California, United States
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Clinical Quality Compliance Specialist
VirtualVocations • Redding, California, United States
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A company is looking for a Clinical Quality Compliance Specialist.
Key Responsibilities
Develop and implement GCP Compliance strategies while managing operational activities within the GCP Compliance function
Host GCP inspections and provide strategic direction to relevant functions and Subject Matter Experts (SME)
Oversee the completion and closure of inspection CAPAs, ensuring timely mitigation of risks and effectiveness checks
Required Qualifications
Minimum of 7 years of relevant experience in the global pharmaceutical industry, including 3 years in GCP Quality / Compliance
Advanced knowledge of pharmaceutical development and GCP / GVP regulations (FDA, EU, MHRA, PMDA, ICH)
Experience in managing operational and compliance metrics, as well as quality inspection risks
Ability to develop and monitor Key Performance / Quality Indicators (KPI / KQI)
Local to Cambridge, MA, with the ability to work onsite 2-3 days a week
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Quality Compliance Specialist • Redding, California, United States
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