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Quality Assurance Manager

  • Anywhere

Company :
PSI CRO

Location :
Durham, North Carolina

Expiry Date :
Mon, 08 Mar 2021 23:59:59 GMT

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Description :
Job Description

Are you dedicated to quality? We are, too. Join our global Quality Management team and be involved in something new and challenging.

COMMUNICATION:

Communication with Company divisions/operational offices with regard to internal systems and locations audits

Communication with vendors with regard to vendor qualification audits by PSI

Backup communication line for customer or third party auditors with regard to issues pertaining to systems audits of PSI

Communication with project teams or Company divisions/offices with regard to follow-up on and resolution of PSI quality assurance (QA) audit observations requiring corrective action

Communication with PSI clients with regard to QA audits contracted to PSI

Communication with project teams and Company divisions with regard to quality management review of essential study documents.

Backup communication line for project teams with regard to onsite/in-house quality assurance study audits and audits of the clinical trial databases

PLANNING AND SCHEDULING:

Preparation, conduct, and reporting of internal systems audits

Preparation, conduct, and reporting of internal locations audits, including remote QA assessments

Preparation, conduct, and reporting of vendor qualification, including remote assessments and onsite audits

Preparation, conduct, and reporting of contracted QA study audits

Preparation, conduct and reporting of mock onsite regulatory inspections

Oversight of the preparation, conduct, and reporting of internal study audits by QA Auditors

May be involved in the preparation, conduct, and reporting of the audits of CSRs

May be involved in the preparation and implementation of corrective action plans in response to external systems audits observations requiring corrective action

May be involved in the oversight of the preparation and implementation of corrective action plans in response to client/third party study audits observations requiring corrective actions

TRAINING:

Participation in training of the PSI Operations staff in quality management issues

Quality management

Participation in the CAPA investigation process

Participation in the investigations of suspected research misconduct

Participation in the QM review of essential study documents

Participation in the review of computer systems validation documentation

Providing assistance and feedback to PSI staff with regards to various GCP, regulatory compliance, and other QM matters