A Manager, Quality Assurance GCP/GLP job in Edison NJ is available courtesy of Adecco Medical & Science. You must have a minimum of a B.S. degree in a scientific or related discipline and/or background in Medical Health Profession. You will manage a fully functional GCP/GLP/CSPV Quality Assurance program that will assure all global studies and the Clinical Safety Pharmacovigilance (CSPV) group and its Partners, Affiliates, and Vendors are in compliance with GCP/GLP/CSPV requirements. We are able to offer a highly competitive salary for this Direct Hire opportunity. Adecco Medical & Science is a division of the world leader in medical and scientific professional recruiting.
Manager, Quality Assurance GCP/GLP job responsibilities include:
Develop and implement Global QA GCP/CSPV objectives and audit schedules including clinical development related audits of investigator sites, laboratories, and internal CSPV systems,
Create specific Quality Assurance SOPs and policies that adhere to regulatory requirements and expectations
Ensure conformance with regulatory requirements globally, good clinical and PV practice and internal standards
Develop, perform, and manage an auditing program that encompasses all phases of clinical development and Clinical Safety Pharmacovigilance and provides assurance
Monitor and review data collection to guard against serious GCP/CSPV non-compliance and fraudulent data capture
Coordination and tracking of document requests, responses and supporting documentation during inspections, tracking of responses after inspections and verification of CAPA commitment implementation
Minimum of a B.S. degree in a scientific or related discipline and/or background in Medical Health Profession
Three plus years' experience with quality assurance and GCP CSPV
Inspection facilitation of FDA and other regulatory agencies
Must be willing to travel 25% of the time
If you are interested in this Manager, Quality Assurance GCP/GLP job in Edison NJ then please click APPLY NOW. For other opportunities available at Adecco Medical & Science go to www.adeccousa.com. If you have questions about the position please contact Eric Wilson at 585-613-3037 or firstname.lastname@example.org
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
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