Manager, Pre‑Clinical & Clinical Compliance

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Quality

Quality & Compliance Audit

Professional

Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America

Clinical and Pre‑Clinical QA Compliance Manager

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.

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.

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/closure of audit findings

The role requires profound understanding of how the GCP requirements are applied into practice, especially with focus across North America and European requirements as well as interpretation of ISO
14155 and ISO
13485 as well as the FDA 21 Part 820. The role includes hands on GCP Quality and GLP Quality activities such as support issue identification and mitigation to our many stakeholders as well as performing audits alone or together with own team members or with support from neighboring teams. The role requires strong collaboration capabilities in a matrix environment across various Quality and Clinical and Preclinical departments.

• Support compliance activities for GLP pre‑clinical and GCP clinical programs, ensuring adherence to regulatory and quality requirements are met according to medical device standards internally and externally
  • Assist with providing clinical compliance oversight and reviews as assigned for clinical study protocols, clinical study manuals, reports, and clinical supporting documentation.
  • Partner with R&D, Clinical, Regulatory Affairs, and Quality teams to support compliant study execution and lifecycle management.
  • Interpret applicable regulations and standards and translate them into practical compliance requirements for study teams.
  • Support GCP clinical and GLP clinical quality assurance internal audits, external audits
  • May support GCP External Clinical Audits/Inspections from Health Authorities including FDA and /or notified body
  • Monitor compliance risks, trends, and findings and elevate as necessary to management
  • May be assigned to facilitate quality control activities, including risk assessment, deviation management, and Corrective and Preventive Actions (CAPA) as applicable
  • Ensure consistent application of global and local compliance procedures, controls, and governance
  • Participate in maintaining the GCP Quality strategies by aligning with global GxP standards, DePuy Synthes Quality Management Systems and DePuy Synthes Quality Policy
  • Develop and execute the annual GCP Clinical and GLP…