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audits clinical trials qms sops fda📋 Description
- Provide ICH/GCP guidance throughout the clinical development life cycle.
- Manage Quality & Compliance activities, including QMS, SOPs, Training and CAPAs.
- Collaborate with Quality/Compliance and Operations to ensure trial compliance.
- Initiate follow-up on suspected misconduct or serious non-compliance.
- Audit regulatory documents for FDA and global authorities (e.g., MHRA).
- Lead corporate quality initiatives and maintain up-to-date regulatory knowledge.
🎯 Requirements
- 20 years in clinical research with emphasis in QA/Compliance.
- Working knowledge of GCP/ICH guidelines and FDA regulations.
- Experience supervising quality personnel.
- Bachelor's degree in science, healthcare, or related field.
- Willingness to travel up to 25% domestically and internationally.
- Experience leading audits.
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