Description
This is an exciting new opportunity with a thriving mid sized Pharma company. We are looking for a QA GCP Manager/Senior Manager who will be responsible for assisting the Director in implementing GCP Quality Assurance programs for the conduct of clinical trials, including conducting and reporting internal/external audits, clinical study reports and other documents; providing compliance advice to clinical project teams and assisting with other departmental needs. A few requirements are as follows;- Plan, conduct and report audits of clinical investigator sites, vendors, clinical study reports, trial master files and other clinical documents (e.g. CTD sections)
- Maintenance of appropriate GCP audit documentation
- Follow up on audit findings and corrective actions to closure
- Identification of compliance issues through the use of internal and external audit programs to minimize regulatory and business risk
- Travel, as required, up to approximately 25% of the time
Requirements:
- At least 4-6 years Clinical QA experience, including internal/external GCP audits, is required
- Demonstrate a thorough knowledge of GCP regulations and guidelines
- Excellent written, oral and interpersonal skills
If you are interested in being submitted for the QA GCP Sr. Manager role, please send you information to b.ross(@)realstaffing.com
Thank you for your time and consideration!
To find out more about Real please visit www.realstaffing.com