
Head of Clinical Quality Assurance (Remote UK)
- Edinburgh
- Permanent
- Full-time
- Help implement and maintain a quality program that complies with Good Clinical Practice (GCP).
- Assist in planning annual schedules for internal, vendor, and project audits.
- Manage or oversee audits of internal systems, vendors, and clinical studies.
- Track and manage corrective and preventive action plans to ensure issues are resolved effectively.
- Oversee quality issue management and escalate serious concerns as needed.
- Support the preparation and review of company policies, standard operating procedures, and other quality documents.
- Provide guidance on quality assurance and regulatory compliance matters.
- Conduct training sessions on GCP and quality-related topics.
- Assist with regulatory inspections and ensure inspection readiness.
- Act as a deputy to the QA Director when required.
- A degree in science or quality management (higher degrees are desirable).
- Strong understanding of GCP, ICH guidelines, and international regulatory requirements.
- Experience in quality assurance or regulatory compliance within the pharmaceutical or related industry.
- Ability to manage workloads and meet deadlines effectively.
- Knowledge of drug safety and pharmacovigilance is a plus.
- Familiarity with inspection readiness processes.
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