Salary Very competition
CY Partners have a new opportunity for you to join a leading Clinical Therapeutic company based in the central belt of Scotland as a QA Manager. The role of QA Manager is responsible for implementing and maintaining Good Clinical Practice (GCP) compliance programs to support the clinical trial activities.
The QA Manager will:
Provide QA oversight to ensure clinical trial activities are conducted in compliance with applicable regulations, ICH GCP guidelines, and internal policies and procedures
manage and conduct internal, investigational site and supplier audits
Host client audits, and serve as the point of contact and host for all regulatory inspections
Promote a GCP compliant environment with internal and external stakeholders while ensuring established quality systems are employed
Assure successful outcomes of client audits and regulatory inspections by managing the sites’ compliance status, proactively identifying and working collaboratively to resolve compliance risks, and maintaining an effective GCP quality system
Serve as audit host for client audits and regulatory inspections.
Lead the resolution of and response, as required, to any audit/inspection findings.
Effectively communicate audit and inspection outcomes to clinical team and Executive Management
Perform detailed review of policies, procedures, work instructions, quality issues, CAPAs, vendor management documents. and other essential documents
Assure all clinical documents, internal, 3rd party and vendor audit records, and study-related documents are appropriately archived
Identify, communicate, and escalate risks, study violations, and serious non-compliance situations
Provide direction for and assure appropriate and timely resolution of violations and non-compliances, acting always with an appropriate sense of urgency
Assure timely issuance of corrective and preventive actions (CAPAs) in response to quality issues and audit observations
Monitor completion of CAPAs to assure thorough root cause investigations, appropriate and effective actions and timely execution
Assure GCP training programs are established, implemented, and maintained for all relevant personnel
Bachelors in a scientific or life sciences discipline. A healthcare background and/or an advance degree preferred.
Key skills & experience
Relevant and increasingly responsible experience in the Biotech/Pharmaceutical Industry in a GCP quality role is essential
Experience in clinical trial monitoring is essential
Clinical trial audit experience is essential.
Knowledge of applicable Global GCP regulations, Good Clinical Practices, ICH Guidelines is essential.
Demonstrated audit conduct experience is essential, including experience supporting regulatory authority inspections.
Excellent oral and written communication skills.
If you are interested in this role or want to enquire further you can contact me via email ([email protected]) or apply directly.