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Senior Quality Assurance Manager

Company: PSI CRO AG
Location: Durham
Posted on: February 25, 2021

Job Description:

Company DescriptionWe are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.Job DescriptionCommunication:* Oversight of communication with project teams with regard to quality assurance onsite/in-house study audits and audits of the clinical trial databases* Oversight of communication with Company divisions with regard to internal systems audits and with the country management with regard to the location audits of the Company operational offices* Oversight of communication with vendors with regard to vendor qualification by PSI* May be involved in communication with customer or third party auditors with regard to issues pertaining to systems audits of PSI* Oversight of communication with project teams or Company divisions/offices with regard to follow-up on and resolution of PSI QA audit observations requiring corrective action* Oversight of communication with PSI clients with regard to QA audits contracted to PSIResource Management And Training* May be involved in resource allocation for QA auditors* Fostering of training, professional development, and career enhancement of QA auditors* Initial and ongoing training of PSI Operations staff in topics related to quality managementPlanning And Scheduling* Participation in the development and implementation of the annual QA audit plan* Oversight of the preparation and maintenance of documentation pertaining to quality assurance onsite/in-house study audits and audits of the clinical trial databases* Assistance in the preparation and implementation of corrective action plans in response to external systems audit observations* Oversight of the preparation and implementation of corrective action plans in response to external study audit observations* May be involved in conducting and reporting of vendor qualification, including remote assessment and onsite audits* Preparation, conduct and reporting of mock onsite regulatory agency inspections* May be involved in the preparation for, attendance at, and follow-up on onsite regulatory agency inspectionsQuality Management* Management of CAPA investigations* May be involved in management of investigations of suspected research misconduct* QA review of essential study documents* Review of computer systems validation documentation* Facilitation of regulatory agency inspections and client/third party audits of PSI* Providing assistance and feedback to all Company staff with regards to various GXP, regulatory compliance, and other QM topics* Participation in the internal and external QA audits findings evaluation, analysis and presentation to senior managementQualifications* College or University degree MD, PharmD or degree in life sciences is a plus* At least 5 years industry experience in clinical research* At least 3 years industry experience in quality assurance* At least 2 years industry experience in a managerial function* Intermediate proficiency in MS Office (Word, Excel, Power Point, Outlook)* Must be a reasonably effective public speakerAdditional InformationIf you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

Keywords: PSI CRO AG, Durham , Senior Quality Assurance Manager, Executive , Durham, North Carolina

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