Description
The Senior Manager of GCP Compliance will be responsible for managing outsourced clinical audits and any audit plans. In this role you will be maintaining the auditor database, conducting co-audits, and ensuring all audit information is included in the Audit Management System.The Senior Manager of GCP Compliance role will be responsible for assessing risk, collaborating and communicating with clinical site auditors, and working with vendors. In addition, within the Compliance team you will be working closely with the Clinical Operations, Data Management, Clinical Scientists, and more.
Key Responsibilities Include:
- Developing the inspection readiness program
- Responsible for understanding compliance risk in regards to pharmaceutical products from Phase I to IV
- Working closely with the Clinical Trial group regarding Quality and auditing issues that arise
- Reviewing audit ready reports and working with CRO's
- Communicating any compliance risks to management
- Overseeing any internal process audits, generating Audit Certificates, and managing any audits of Investigator sites, Vendors, Commercial IRBs, and Clinical Study Reports
Key Requirements Include:
- Bachelor's Degree and at least 8 years of relevant experience
- Master's Degree and at least 5 years of relevant experience
- Clear understanding of the Quality industry within pharmaceuticals and biotech industry
- Experience within Clinical Auditing
To find out more about Real please visit www.realstaffing.com