Manager, Pre‑Clinical & Clinical Compliance

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Job Function:
Quality

Job Sub Function:
Quality & Compliance Audit

Job Category:
Professional

All Job Posting Locations:
Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

Clinical and Pre‑Clinical QA Compliance Manager

Job Description:

DePuy Synthes is recruiting for a Clinical and Pre-Clinical QA Compliance Manager, to be located in one of the following locations: Raynham MA or Palm Beach Gardens FL or West Chester PA.

Job Overview

For the DePuy Synthes organization, the Clinical and Pre-Clinical QA Compliance Manager main job responsibilities include conducting internal and external GCP Clinical Quality Assurance (QA) audits which include system, program and clinical site investigator sites as well as GLP Preclinical Quality Assurance Supplier Audits.

Additionally, this role will include GCP projects relative to supporting compliance activities across clinical research programs within Orthopedics.

This role will support the clinical study design, execution, documentation, and oversight in compliance with applicable external regulations, quality standards, and internal policies.

This particular position plays a critical role in protecting patient safety, ensuring data integrity and enabling compliant advancement of products through the development lifecycle by partnering closely with stakeholders across R&D, Clinical Research, Regulatory Affairs, Medical Affairs and Quality teams.

The Role
In the role as Clinical and Pre-Clinical QA Compliance Manager, GCP Quality activities include GCP Clinical and GLP Preclinical audits will include the following:


* Preparation prior to the audit, connecting with the clinical research team identified and providing advanced notice including securing availability to conduct the audit


* Conducting the audit including interviewing the clinical research team and reviewing documents requested


* Facilitating an audit close-out meeting and issuing a audit report including observations cited for follow-up as applicable


* Follow-up as required, on the status...